Electrosurgical devices, electrosurgical unit and methods of use thereof

ABSTRACT

A cartridge assembly to couple an electrosurgical device to treat tissue with an electro surgical unit includes a cartridge member to operate with a power delivery apparatus of the electro surgical unit and a fluid delivery apparatus of the electro surgical unit. An electrosurgical unit includes a power delivery apparatus and a fluid delivery apparatus arranged to operate with a cartridge member to be located in a cartridge receptacle of the electrosurgical unit. An electrosurgical device includes a first electrode spaced alongside the second electrode, with each electrode having a blade shaped member. Each blade shaped member has opposing sides bounded by edges, with the edges having a medial edge and a lateral edge. At least one fluid outlet is adjacent each blade shaped member, and each fluid outlet is in fluid communication with a fluid passage. The device can be operated as either a bipolar device or a monopolar device and includes a switch to inhibit capacitive coupling to one of the electrodes when the other electrode is used in monopolar fashion.

This application is a continuation of U.S. application Ser. No. 14/593,312, filed Jan. 9, 2015, which is in turn a divisional of U.S. application Ser. No. 13/006,940, filed Jan. 14, 2011, now U.S. Pat. No. 9,050,113, issued on Jun. 9, 2015, entitled ELECTROSURGICAL DEVICES, ELECTROSURGICAL UNIT AND METHODS OF USE THEREOF, which claims the benefit of U.S. Provisional Patent Application No. 61/295,513, entitled ELECTRO SURGICAL DEVICES, ELECTROSURGICAL UNIT AND METHODS OF USE THEREOF, filed on Jan. 15, 2010, the entireties of which are incorporated herein by reference.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

n/a

FIELD OF THE INVENTION

This invention relates generally to the field of medical devices, systems and methods for use upon a human body during surgery. More particularly, the invention relates to electro surgical devices, systems and methods that provide for cutting of tissue in addition to coagulation, hemostasis, and sealing of tissue to inhibit blood and other fluid loss during surgery, such as abdominal, orthopedic, head, spine and thoracic surgery as well as general surgery of the body.

BACKGROUND OF THE INVENTION

U.S. Patent Application Publication 2002/0198519 published Dec. 26, 2002, in the name of Qin et al. discloses an integrated device having a radio frequency generator 38, controller 52 with I/O device 54, and a fluid delivery apparatus 44 (e.g., for the delivery of cooling liquid) are integrated within a single housing 400. Electrical connection of a disclosed treatment device 26 a 126 b to the integrated device is performed by connecting an electrical connector 408 of the treatment device 26 a 126 b to electrical connector 402 of the integrated device. Device 26 a 126 b can also be separately connected via tubing 12 to the fluid delivery apparatus 44, to convey processing fluid for discharge by or near an operative element 36 a 136 b.

From Qin et al., since the connection of electrical connector 408 to electrical connector 402 and tubing 12 to fluid delivery apparatus 44 are performed separately as separate steps and not integrated, the time for preparing the system for use may be increased or delayed if one individual is preparing the system, or two individuals may be required to prepare the system if the electrical connection and fluid connection are to be preformed simultaneously.

In addition, as shown in Qin et al., fluid delivery apparatus 44 includes a pump rotor 428. As indicated, the physician can couple the source of cooling liquid to the appropriate port on the handle of the device 26 a 126 b and load the tubing leading from the source of cooling liquid (e.g., a bag containing sterile water) in the pump rotor 428. However, it may be possible to install the tubing improperly, for example, in the wrong direction (i.e. backwards) in such a way that the pump rotor 428 pumps fluid towards the source of cooling liquid rather than device 26 a 126 b. Furthermore, even if the direction of the tubing is proper, it may be possible to misalign the tubing with the pump rotor 428 such that the rotor 428 does not interact properly with the tubing causing a restriction in fluid flow, such as by improperly pinching the tubing, or even damaging the tubing, such as causing a leak. Also, if fluid is introduced into the tubing 12 before the tubing 12 is installed in fluid delivery apparatus 44 it may be possible for the fluid to flow uninhibited through the tubing and leak from treatment device 26 a 126 b. As a result, the foregoing installation errors, set-up and use of the equipment may be further delayed.

In light of the above, what is needed is a structure, method and system in which a medical device to treat tissue can be connected to a power delivery apparatus, such as a radio-frequency generator, and a fluid delivery apparatus, such as a pump, while overcoming the aforementioned deficiencies in the art, and may enable a single individual to connect the device to both of the power delivery apparatus and fluid delivery apparatus substantially simultaneously and without installation error to expedite use thereof.

SUMMARY OF THE INVENTION

In one embodiment, the invention provides source equipment for use with a device to treat tissue, with the source equipment comprising a power delivery apparatus to deliver power provided from a power source to the tissue treatment device and a fluid delivery apparatus to deliver a fluid provided from a fluid source to the tissue treatment device. The power delivery apparatus and the fluid delivery apparatus are arranged to operate with a cartridge member to be placed in a cartridge receptacle of the source equipment.

The source equipment may comprise an electrosurgical unit and the tissue treatment device may further comprise an electro surgical device.

The power delivery apparatus may comprise a radio-frequency power delivery apparatus to deliver radio-frequency power from a radio-frequency power source to the electro surgical device. The radio-frequency power source may comprise a radiofrequency generator located in the electro surgical unit.

The fluid delivery apparatus may further comprise a pump, more particularly a peristaltic pump and even more particularly a rotary peristaltic pump. The fluid source may comprise a container containing a fluid, such as a bag containing a liquid. More particularly, the fluid source may comprise an LV. bag containing normal (physiologic or 0.9%) saline solution.

The source equipment may comprise a releasable engagement mechanism to engage and disengage with the cartridge member, as well as a releasable positioning mechanism to position the cartridge member.

The power delivery apparatus and/or the fluid delivery apparatus may be capable of being in a use position or a non-use position. The power delivery apparatus and/or the fluid delivery apparatus may be movable, such as by mechanical movement, to engage with the cartridge member or disengage from the cartridge member. The power delivery apparatus and/or fluid delivery apparatus may be movable by operation of an actuator (e.g. motor) or manually (e.g. by hand). The power delivery apparatus and fluid delivery apparatus may be simultaneously and/or jointly moveable.

In another embodiment, the invention provides a cartridge assembly to couple a device to treat tissue with source equipment, with the cartridge assembly comprising a cartridge member to be placed in a cartridge receptacle of the source equipment, and the cartridge member to operate with a power delivery apparatus of the source equipment and a fluid delivery apparatus of the source equipment.

The source equipment may comprise an electrosurgical unit and the tissue treatment device may further comprise an electrosurgical device.

The cartridge member may receive a radio-frequency power output from the electro surgical unit, which may comprise bipolar radio-frequency power or monopolar radio-frequency power. The cartridge member may be electrically coupled to one or more electrodes of the electro surgical device to provide the radio-frequency power output to the one or more electrodes.

The cartridge member may receive a control signal from the electrosurgical unit. The control signal may comprise a signal to control a radio-frequency power output of the electro surgical unit. The cartridge member may be electrically coupled to a radiofrequency power activation switch of the electrosurgical device to provide the signal to the radio-frequency power activation switch.

The cartridge member may include electrosurgical device information, and may provide the electro surgical device information to the electrosurgical unit, with the electrosurgical device information in a format which may be readable by the electro surgical unit. The electro surgical device information may be stored on a storage media.

The electro surgical device information may provide at least one operating parameter for a use of the electro surgical device. The electro surgical device information may provide at least one of a radio-frequency power level setting and a fluid flow level setting for a use of the electro surgical device. The electronic device information may also provide a default setting for a use of the electrosurgical device, a time interval for a use of the electro surgical device or at least one identifier unique to the electrosurgical device.

The cartridge member may provide an electrical contact which may be located on a printed circuit board. The electrical contact may be contacted by a pogo (spring loaded) pin of the electro surgical unit.

The cartridge member may provide a storage media. The storage media may comprise an electronic memory, which may further comprise a programmable read only memory.

The cartridge member may provide a fluid delivery passage to operate with the fluid delivery apparatus of the electro surgical unit. A length of the fluid delivery passage may be defined by a segment of tubing, which may be compressed by an operation of the fluid delivery apparatus. The cartridge member may provide a cartridge body, and a length of the fluid delivery passage may be defined by the cartridge body.

The cartridge member may provide a valve, with the valve in fluid communication with a fluid delivery passage. The valve may at least partially close the fluid delivery passage when the fluid delivery apparatus is inactive. The valve may comprise a check valve and more precisely a diaphragm check valve.

In another embodiment, the invention provides a method of providing an electrosurgical system, with the method comprising:

providing an electro surgical unit having a power delivery apparatus and a fluid delivery apparatus, wherein the power delivery apparatus and the fluid delivery apparatus are arranged to operate with a cartridge member to be placed in a cartridge receptacle of the electrosurgical unit;

providing the cartridge member; placing the cartridge member in the cartridge receptacle of the electro surgical unit; engaging the cartridge member with the power delivery apparatus of the electro surgical unit; and engaging the cartridge member with the fluid delivery apparatus of the electro surgical unit.

Engaging the cartridge member with the power delivery apparatus of the electro surgical unit may comprise contacting an electrical contact of the cartridge member with an electrical contact of the power delivery apparatus.

Engaging the cartridge member with the fluid delivery apparatus of the electro surgical unit may comprise compressing a fluid delivery tubing segment of the cartridge member with a compression element of the fluid delivery apparatus.

Engaging the cartridge member with the power delivery apparatus of the electro surgical unit may comprise moving the power delivery apparatus from a non-use position to a use position; and engaging the cartridge member with the fluid delivery apparatus of the electro surgical unit may comprise moving the fluid delivery apparatus from a non-use position to a use position. The power delivery apparatus and fluid delivery apparatus may be moved simultaneously and/or jointly.

In another embodiment, the invention provides an electrosurgical device which comprises a first electrode spaced alongside a second electrode, with each electrode comprising a blade shaped member. Each blade shaped member has opposing sides bounded by edges, with the edges comprising a medial edge and a lateral edge. At least one fluid outlet is adjacent each blade shaped member and each fluid outlet in fluid communication with a fluid passage.

Each blade shaped member may have the same size and shape and comprise a sheet metal and/or a stamped metal strip. Each blade member may have a length in a range of and any increment between 6 mm to 15 mm, a width in a range of and any increment between 2 mm to 3 mm, and a thickness in a range of and any increment between 0.25 mm to 0.75 mm.

A distal end of each blade shaped member may be rounded from the medial edge to the lateral edge of the blade shaped member, and the rounded distal end of each blade shaped member may be defined by a radius.

A distal portion of each blade shaped member may be at an obtuse angle relative to a proximal portion of the blade shaped member. Each obtuse angle may have a vertex extending across a width of each blade shaped member, and be in a range of and any increment between 91 degrees to 179 degrees.

A distal portion of each blade shaped member may include a protrusion on at least one side of the blade shaped member. Each protrusion may comprise a convex curvature on one side of the blade shaped member.

A distal portion of each blade shaped member may include a protrusion on at least one side of the blade shaped member. Each protrusion may comprise a convex curvature on one side of the blade shaped member.

A distal portion of each blade shaped member may include a recess on at least one side of the blade shaped member. Each recess may comprise a concave curvature on one side of the blade shaped member.

The first electrode may be distal to a distal end of a first electrically conductive tube and the second electrode may be distal to a distal end of a second electrically conductive tube. The at least one fluid outlet adjacent the first blade shaped member may be located at a distal end of the first electrically conductive tube and the at least one fluid outlet adjacent the second blade shaped member may be located at a distal end of the second electrically conductive tube.

The blade members may be coplanar. At least a portion of one of the opposing sides of the first blade member may be coplanar and/or parallel with at least a portion of one of the opposing sides of the second blade member. At least a portion of each opposing side of the first blade member may be coplanar and/or parallel with a corresponding opposing side of the second blade member.

The first and second electrodes may be configured as bipolar electrodes, and at least one of the electrodes may be configured as a monopolar electrode.

The first and second electrodes may be configured to treat tissue by moving along a tissue surface in a presence of a bipolar power output and a fluid provided simultaneously from the fluid outlets.

In another embodiment, the invention provides an electrosurgical device, comprising a first electrode and a second electrode; a switch to activate and deactivate bipolar power to the first and second electrodes from a radio-frequency generator to be coupled to the device, the switch comprising a double pole, single throw switch, and a switch to activate and deactivate monopolar power to the first electrode from the radiofrequency generator to be coupled to the device, the switch comprising a single pole, single throw switch.

The double pole, single throw switch may form a control circuit with the radio-frequency generator to be coupled to the device, with the circuit to control activation of the bipolar power from the radio-frequency generator when the double pole, single throw switch is in a closed position, and control deactivation of the bipolar power from the radio-frequency generator when the double pole, single throw switch is in an open position.

The double pole, single throw switch may be in series between the second electrode and a bipolar power output of the radio-frequency generator to be coupled to the device.

The double pole, single throw switch may connect the second electrode with a bipolar power output of the radio-frequency generator in a closed position and disconnect the second electrode with the bipolar power output of the radio-frequency generator in an open position.

The single pole, single throw switch may form a control circuit with the radio-frequency generator to be coupled to the device, with the circuit to control activation of the monopolar power from the radio-frequency generator when the single pole, single throw switch is in a closed position, and control deactivation of the monopolar power from the radio-frequency generator when the single pole, single throw switch is in an open position.

The switch to activate and deactivate bipolar power and the switch to activate and deactivate monopolar power may be both located on a hand-piece of the device.

In another embodiment, the invention provides an electrosurgical device comprising a first electrode and a second electrode, a switch to activate and deactivate monopolar power to the first electrode of the device from a radio-frequency generator to be coupled to the device, and a switch to inhibit capacitive coupling of the second electrode to the monopolar power.

The switch to activate and deactivate monopolar power to the first electrode of the device from a radio-frequency generator to be coupled to the device may comprise a single pole, single throw switch.

The switch to activate and deactivate monopolar power to the first electrode of the device from a radio-frequency generator to be coupled to the device may form a control circuit with the radio-frequency generator to be coupled to the device, with the circuit to control activation of the monopolar power from the radio-frequency generator when the switch is in a closed position, and control deactivation of the monopolar power from the radio-frequency generator when the switch is in an open position.

The switch to inhibit capacitive coupling of the second electrode to the monopolar power

The switch to inhibit capacitive coupling of the second electrode to the monopolar power may form a control circuit with the radio-frequency generator to be coupled to the device, with the circuit to control activation of bipolar power from the radio-frequency generator when the switch is in a closed position, and control deactivation of the bipolar power from the radio-frequency generator when the switch is in an open position.

The switch to inhibit capacitive coupling of the second electrode to the monopolar power may be in series between the second electrode and a bipolar power output of the radio-frequency generator to be coupled to the device.

The switch to inhibit capacitive coupling of the second electrode to the monopolar power may connect the second electrode with a bipolar power output of the radio-frequency generator in a closed position and disconnect the second electrode with the bipolar power output of the radio-frequency generator in an open position.

The switch to activate and deactivate monopolar power and the switch to inhibit capacitive coupling of the second electrode to the monopolar power may be both located on a hand-piece of the device.

In another embodiment, the invention provides an electro surgical device comprising a first electrode and a second electrode and a switch having a first position to activate monopolar power to the first electrode of the device from a radio-frequency generator to be coupled to the device and to inhibit capacitive coupling of the second electrode to the monopolar power.

The switch may have a second position to deactivate the monopolar power to the first electrode of the device from a radio-frequency generator to be coupled to the device and to connect the second electrode with a bipolar power output of the radio-frequency generator.

In another embodiment, the invention provides a first electrode and a second electrode, each electrode to receive radio frequency power from first and second wire conductors, respectively, and a switch having a first position to activate monopolar power to the first electrode of the device from a radio-frequency generator to be coupled to the device and to disconnect the second electrode from the second conductor.

The switch may have a second position to deactivate the monopolar power to the first electrode of the device from a radio-frequency generator to be coupled to the device and to connect the second electrode to the second conductor.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention may be more completely understood in consideration of the following detailed description of various embodiments of the invention in connection with the accompanying drawings, in which:

FIG. 1 is a perspective view of an electrosurgical device with a cartridge assembly having a cartridge member to connect a hand-piece to an electrosurgical unit according to one embodiment of the invention;

FIG. 2 is a top view of the cartridge member;

FIG. 3 is a bottom view of the cartridge member;

FIG. 4 is a perspective view of the cartridge assembly showing the inner components of the cartridge member;

FIG. 5 is a plan view of the cartridge assembly showing the inner components of the cartridge member;

FIG. 6 is a plan view showing certain fluid passages of the electro surgical device;

FIG. 7 is a diagram of the various electrical connections of a printed circuit board assembly provided with the cartridge member;

FIG. 8 is a top plan view of the printed circuit board assembly;

FIG. 9 is a bottom plan view of the printed circuit board assembly;

FIG. 10 is a top view of the upper (top) layer of the printed circuit board assembly;

FIG. 11 is a top view of the lower (bottom) layer of the printed circuit board assembly;

FIG. 12a is a plan view showing certain electrical connections of the electrosurgical device;

FIG. 12b is a plan view showing alternative electrical connections of the electro surgical device;

FIG. 12c is a plan view showing alternative electrical connections of the electrosurgical device;

FIG. 13 is a close-up view of the shaft assembly of the device;

FIG. 14 is a close-up cross-sectional view of the electrodes of the device of FIG. 1 taken along line 14-14 of FIG. 13;

FIG. 15 is a close-up cross-sectional view of a distal end portion of the device of FIG. 1 taken perpendicular to line 14-14 of FIG. 13;

FIG. 16a is a perspective view of an electro surgical device according to another embodiment of the invention;

FIG. 16b is a close-up perspective view of a distal portion of the device of FIG. 16 a;

FIG. 16c is a close-up plan view of a distal portion of the device of FIG. 16 a;

FIG. 16d is a close-up cross sectional view of the device of FIG. 16a taken perpendicular to line 16 d-16 d of FIG. 16 c;

FIG. 16e is a close-up plan view of an electrode of the device of FIG. 16 a;

FIG. 16f is a close-up cross sectional view of the electrode of FIG. 16e taken perpendicular to line 16 f-16 f of FIG. 16 e;

FIG. 16g is another close-up perspective view of the distal portion of the device of FIG. 16 a;

FIG. 16h is a close of perspective view of an alternative embodiment of the electrode of FIG. 16 a;

FIG. 16i is a close of perspective view of an alternative embodiment of the electrode of FIG. 16 a;

FIG. 16j is a close of perspective view of an alternative embodiment of the electrode of FIG. 16 a;

FIG. 16k is a close of perspective view of an alternative embodiment of the electrode of

FIG. 16 a;

FIG. 16l is a close of perspective view of a distal portion of an alternative embodiment of the device of FIG. 16 a;

FIG. 17a is a perspective view of an electrosurgical unit according to one embodiment of the invention;

FIG. 17b is a perspective view of the electro surgical unit with the cartridge member of the cartridge assembly installed;

FIG. 18 is a perspective view of the electro surgical unit;

FIG. 19 is a front perspective view of the electro surgical unit's docking assembly with a movable docking mechanism in the up (non-use) position prior to the docking mechanism engaging with the cartridge member;

FIG. 20 is a front view of the docking assembly with the docking mechanism in the up position;

FIG. 21 is a right side view of the docking assembly with the docking mechanism in the up position;

FIG. 22 is a left side view of the docking assembly with the docking mechanism in the up position;

FIG. 23 is a rear view of the docking assembly with the docking mechanism in the up position;

FIG. 24 is a top view of the docking assembly with the docking mechanism in the up position;

FIG. 25 is a rear perspective view of the docking assembly with the docking mechanism in the up position;

FIG. 26 is a rear perspective view of the docking assembly with the docking mechanism in the down (use) position;

FIG. 27 is a rear perspective view of a locking mechanism with the docking mechanism in the up position;

FIG. 28 is rear perspective view of the locking mechanism of with the docking mechanism in the down position;

FIG. 29 is an exploded view of the cartridge member, upper receptacle enclosure, lower receptacle enclosure and a fluid delivery apparatus;

FIG. 30 is a cross sectional view taken through cartridge member, upper receptacle enclosure, lower receptacle enclosure and a fluid delivery apparatus at line 3030 of FIG. 24;

FIG. 31 is a perspective view of the upper receptacle enclosure with a radio-frequency power delivery apparatus;

FIG. 32 is a side view of the upper receptacle enclosure with the radio-frequency power delivery apparatus;

FIG. 33 is a bottom view of the upper receptacle enclosure with a radio-frequency power delivery apparatus;

FIG. 34 is a perspective view of an electrical contact assembly for the radio-frequency power delivery apparatus comprising an electrical insulator/carrier and electrical contacts;

FIG. 35 is a cross sectional perspective view of the electrical contact assembly of FIG. 34;

FIG. 36 is a cross sectional view of the electrical contact assembly and cartridge member;

FIG. 37 is a front view of one embodiment of a system of the present invention having electro surgical unit in combination with a fluid source and handheld electro surgical device;

FIG. 38 is a display screen for the electro surgical unit requesting insertion of the cartridge member;

FIG. 39 is a display screen for the electro surgical unit requesting priming of the electrosurgical device with fluid;

FIG. 40 is a display screen for the electrosurgical unit showing the electrosurgical unit and system is ready for operation;

FIG. 41 is a display screen for the electro surgical unit showing radio-frequency power is being provided from the unit;

FIG. 42 is an exemplary graph showing a relationship of fluid flow rate Q in units of cubic centimetres per minute (cc/min) on the Y-axis, and the RF power setting P.sub.s in units of watts on the X-axis;

FIG. 43 is an exemplary graph of the bipolar RF power output versus impedance for the electrosurgical unit;

FIG. 44 is an exemplary graph of the bipolar RF power output versus impedance for the electrosurgical unit;

FIG. 45 is a close-up view of a distal end portion of the device of FIG. 1 with an exemplary fluid coupling to a tissue surface of tissue;

FIG. 46 is a perspective view of the device of FIG. 1 cutting tissue; and

FIG. 47 is a close-up view of a distal end portion of the device of FIG. 16a with an exemplary fluid coupling to a tissue surface of tissue.

DETAILED DESCRIPTION OF THE INVENTION

Throughout the description, like reference numerals and letters indicate corresponding structure as may also be shown in the figures. Also, any particular feature(s) of a particular embodiment may be equally applied to any other embodiment(s) of this specification as suitable. In other words, features between the various embodiments described herein are interchangeable as suitable, and not exclusive. From the specification, it should be clear that any use of the terms “distal” and “proximal” are made in reference from the user of the device, and not the patient.

The inventions disclosed herein provide devices, systems and methods for treating tissue at a tissue treatment site during an electrosurgical procedure. Among other features, the inventions disclosed herein are particularly useful for procedures where it may be desirable to cut tissue, as well as shrink, coagulate and seal tissue against blood and other fluid loss, for example, by shrinking lumens of blood vessels (e.g., arteries, veins).

The invention will now be discussed with reference to the figures, with FIG. 1 showing an exemplary handheld electrosurgical device 10 according to one embodiment of the present invention, which may be used in conjunction with a system of the present invention. Accordingly, it should be understood that the structure of device 10 is not intended to be limiting as to the scope of devices which can be used with the system of the invention.

As shown in FIG. 1, exemplary device 10 comprises an elongated hand-piece 12 having a handle 14 provided by mating handle portions 14 a, 14 b. Hand-piece 12 may be slender to enable a user of device 10 to hold and manipulate device 10 between the thumb and index finger like a writing instrument such as a pen. Hand-piece 12 may comprise a sterilizable, rigid, electrically insulative material, such as a plastic material. Exemplary plastic materials may comprise polycarbonate (PC) and acrylonitrile-butadiene-styrene (ABS).

Device 10 may be coupled to an electro surgical unit 300 (shown in FIG. 17a ) by a cartridge assembly 16 comprising cartridge member 18. As shown in FIGS. 2 and 3, cartridge member 18 comprises a substantially planar, elongated, rectangular cartridge body 20 comprising mating cartridge body portions 20 a, 20 b. To facilitate proper installation of cartridge member 18 with electro surgical device 300, cartridge body 20 a may include a directional indicator 30 to show the direction in which cartridge member 18 is to be installed in electrosurgical unit 300, as well as which side of the cartridge member 18 is the top surface. Furthermore, cartridge body 20 a includes a protruding element 28, shown in the form of an elongated rib, to physically prevent installation of the cartridge assembly 16 upside down. Cartridge body 20 may be made of a sterilizable, rigid, electrically insulative material, such as a plastic material. Exemplary plastic materials may comprise polycarbonate (PC) and acrylonitrile-butadiene-styrene (ABS).

Referring briefly to FIG. 37, when device 10 is connected to other components as part of a system, fluid 502 from a fluid source 500, such as a bag of saline solution, may be communicated through an enclosed fluid passage provided by various structures. Fluid 502 flows from the fluid source 500 into cartridge member 18 of cartridge assembly 16 through lumen 44 of flexible fluid delivery tubing segment 46. At one end, fluid delivery tubing segment 46 preferably couples to fluid source 500 through a drip chamber 48 after the fluid source 500 may be penetrated with a spike 50 located at the end of the drip chamber 48 in a known manner. In other embodiments, drip chamber 48 may be eliminated and tubing segment 46 may be attached directly to a spike 50. Fluid delivery tubing segment 46 may be made of a plastic material, such as flexible polyvinyl chloride (PVC) or other flexible material such as an elastomer.

Referring now to FIGS. 4 and 5, at its opposite end, fluid delivery tubing segment 46 may be coupled and tightly fastened with a fluid tight connection to cartridge body 20 b of cartridge member 18 via a female connector portion 60. More particularly, fluid delivery tubing segment 46 may be coupled to cartridge body 20 b via a distal end portion of the tubing segment 46 extending into a cylindrical cavity 62 formed in cartridge body 20 b to provide a cylindrical receptacle. The outer surface of fluid delivery tubing segment 46 may be configured to mate against and form a press (interference) fit seal with corresponding inner surfaces of connector portion 60 to provide a fluid tight seal there between. An adhesive or solvent bonding may be used there between to further strengthen the seal, or in lieu of the press fit.

Continuing with FIG. 5, from lumen 44 of fluid delivery tubing segment 46, the fluid passage extends through a through hole 64 provided at the base of cavity 62 and may be next provided and defined by an elongated enclosed channel 68 formed by overlying portions of cartridge bodies 20 a, 20 b. More particularly, channel 68 may be formed by mating a channel portion 68 a of cartridge body 20 a with a channel portion 68 b of cartridge body 20 b and forming a continuous hermetic seal there between, particularly by vibration, ultrasonic or other plastic welding method.

From channel 68, the fluid passage thereafter extends through a through hole 72 formed in male connector portion 74, into lumen 76 of fluid delivery tubing segment 78 and thereafter through hole 80 formed in male connector portion 82. As shown in FIG. 5, fluid delivery tubing segment 78 may be coupled and tightly fastened with a fluid tight connection to cartridge body 20 b of cartridge member 18 via male connector portions 74 and 82 provided by two spaced, parallel, fixed supports 84 and 86 at the opposite ends thereof. More particularly, fluid delivery tubing segment 78 may be coupled to cartridge body 20 b via male connector portions 74 and 82 which extend into the lumen 76 of delivery tubing segment 78. The inner surface of lumen 76 of fluid delivery tubing segment 78 may be configured to mate against and form a press (interference) fit seal with corresponding outer surfaces of connector portions 74 and 82 to provide a fluid tight seal there between. An adhesive or solvent bonding may be used there between to further strengthen the seal, or in lieu of the press fit. Similar to fluid delivery tubing segment 46, fluid delivery tubing segment 78 may be made of a plastic material, such as flexible polyvinyl chloride (PVC) or other flexible material such as an elastomer.

It may be possible to replace fluid delivery tubing segment 78 to Increase or decrease the fluid flow output of fluid delivery apparatus 420 (discussed in greater detail below) by changing the size (diameter) of lumen 76 of delivery tubing segment 78. Furthermore, fluid delivery tubing segment 78 may require a thicker cross-section and durability than the other fluid delivery tubing segments, such as fluid delivery tubing segment 46. For example, in a particular embodiment discussed in greater detail below, fluid delivery tubing segment 78 may be configured to be compressed by a fluid delivery apparatus 422 contained within electrosurgical unit 300, to force fluid 502 through the lumen 76 thereof in a known manner. In such instance, the thicker portion of the fluid delivery tubing for device 10 may be limited to fluid delivery tubing segment 78.

Continuing with FIG. 5, from through hole 80 of connector portion 82, the fluid passage extends into a cylindrical chamber 90 of a one-way (check) diaphragm valve 38 (FIG. 1) provided and defined chamber portions 90 a and 90 b which are separated by a flat disc shaped plastic membrane 92. With valve 38, fluid 502 only may flow in one direction. In use, when valve 38 is open, membrane 92 may be positioned towards the end of chamber portion 90 a and fluid may be allowed to pass through chamber 90 and into through hole 98 to exit chamber 90. In order to inhibit back flow of fluid 502, when valve 38 is closed, membrane 92 may be positioned on seat 96 in a cavity of cartridge body 20 b, which closes the fluid passage and fluid communication between the exit port provided by through hole 98 and the inlet port provided by through hole 80. Furthermore, membrane 92 inhibits fluid 502 from flowing through valve 38 if the fluid pressure is less than about 3.5 psi. In this manner, fluid 502 may not flow through valve 38 to handpiece 12 in the event fluid 502 is introduced to the fluid passage before cassette member 18 may be installed in electrosurgical unit 300, but rather will only open to permit flow there through when a pressure of greater than 3.5 is provided by fluid delivery apparatus 420 after cartridge member 18 has been installed in electro surgical unit 300.

From through hole 98, the fluid passage extends into lumen 104 of fluid delivery tubing segment 106. Similar to fluid delivery tubing segment 46, tubing segment 106 may be coupled and tightly fastened with a fluid tight connection to cartridge body 20 a of cartridge member 18 via a female connector portion 110. More particularly, fluid delivery tubing segment 106 may be coupled to cartridge body 20 a via a distal end portion of the tubing segment 106 extending into a cylindrical cavity 112 formed by cartridge body 20 a to provide a cylindrical receptacle. The outer surface of fluid delivery tubing segment 106 may be configured to mate against and form a press (interference) fit seal with corresponding inner surfaces of connector portion 110 to provide a fluid tight seal there between. An adhesive or solvent bonding may be used there between to further strengthen the seal, or in lieu of the press fit. As shown in FIG. 5, tubing segment 106 may be molded and formed unitary with cord 40, such as by plastic co-extrusion, to provide a single cable 42.

Referring to FIG. 6, fluid delivery tubing segment 106 enters the proximal end of hand-piece 12 of electro surgical device 10. Within hand-piece 12 of device 10, fluid delivery tubing segment 106 may be connected to the inlet branch of a Y-splitter 118, which thereafter provides two outlet branches which are connected to the proximal ends of fluid delivery tubing segments 120 a, 120 b. The distal ends of delivery tubing segments 120 a, 120 b are thereafter connected to the proximal ends of shafts 124 a, 124 b. To connect fluid delivery tubing segments 120 a, 120 b to shafts 124 a, 124 b, the lumens 122 a, 122 b of the fluid delivery tubing segments 120 a, 120 b are preferably interference fit over the outside diameter of shafts 124 a, 124 b to provide an interference fit seal there between. An adhesive or solvent bonding may be used there between to further strengthen the seal, or in lieu of the press fit. Fluid 502 may then flow through the lumens 126 a, 126 b of shafts 124 a, 124 b and thereafter exit from device 10 as discussed in greater detail below.

Additionally, device 10 may include an aspiration/suction tubing segment to remove fluid 502 from a tissue treatment site. The suction tubing segment may pass through cartridge member 18 and thereafter be connected to a vacuum source.

In addition to operating in conjunction with a fluid delivery apparatus 422 within electrosurgical unit 300, as discussed in greater detail below, cartridge assembly 16 also operates in conjunction with a radio-frequency power delivery apparatus 440 and other electrical components and circuits within electrosurgical unit 300.

As shown in FIGS. 1 and 2, as well as FIGS. 4 and 5, cartridge member 18 includes a two layer printed circuit board 24, one side of which may be exposed through an aperture 32 in cartridge body 20 a of cartridge member 18 to provide an electrical communication with electro surgical unit 300. Printed circuit board 24 may comprise a 0.05-0.07 inch thick base insulator with top and bottom conductive layers deposited thereon. The exposed conductive layers may more particularly comprise 2-6 microns of gold over 100-300 microns of electroless nickel over copper. Detailed drawings of printed circuit board 24 may be found in FIGS. 7-11.

As shown in FIGS. 7-11, printed circuit board 24 includes a plurality of electrical contacts thereon, which may comprise electrical contact pads to electrically couple with corresponding electrical contacts of electro surgical unit 300. Certain of these electrical contacts and their associated function will now be discussed.

Bipolar radio-frequency power from electrosurgical unit 300 may be provided from outputs BP+ and BP− thereof. As shown in FIG. 7, electrical contacts J1OIJ27 receive power from bipolar power output BP+ which may then communicated along an electrically conductive pathway to electrical contacts J25/J28. Electrical contacts J11/J16 receive power from bipolar power output BP-which may then communicated along an electrically conductive pathway to electrical contacts J26/J29. Electrical contacts J10/J27 and J11/J16 are shown in FIG. 8, while electrical contacts J25/J28 and J26IJ29 are shown in FIG. 9.

As best shown in FIG. 5, electrical contacts J28 and J29 are coupled to the proximal end of insulated wire conductors 130 a and 130 b, respectively, of electrical cord 40. As shown in FIG. 12, the distal end of insulated wire conductors 130 a, 130 b ultimately couple with the bipolar electrodes 180 a, 180 b of device 10 as discussed in greater detail below.

Additionally, electro surgical unit 300 may be operated in a monopolar mode with monopolar power provided through power output BP+, in which case power output BP− is no longer utilized. Rather, as shown in FIG. 12, an additional cord 132 is utilized to connect a ground pad dispersive electrode 134, which is located on the patient, to the electro surgical unit 300 using wire conductor 136 and plug 138 at the end thereof which connects to the ground pad receptacle 308 (as shown in FIGS. 16 and 17).

During monopolar operation, an electrode of device 10 is used in conjunction with ground pad dispersive electrode 134 which is placed on the patient (also known as a patient return electrode or neutral electrode), typically on the back or other suitable anatomical location. An electrical circuit is formed between the electrode of device 10 and ground pad dispersive electrode 134 with electrical current flowing from the device electrode through the patient to ground pad dispersive electrode 134 in a manner known in the art.

During bipolar operation, the ground pad electrode 134 located on the patient is not required, and a second electrode providing an electrical pole is provided as part of device 10. An alternating current electrical circuit is then created between the first and second electrical poles of the device. Consequently, alternating current no longer flows through the patient's body to the ground pad electrode 134, but rather through a localized portion of tissue between the poles of the bipolar electrodes. Monopolar and bipolar power may be provided from electro surgical unit 300 in a manner known in the art.

Returning to FIG. 7, a control signal from electrosurgical unit 300 may be provided to electrical contact J14, which is configured to receive a control signal from electrosurgical unit 300 as part of a control circuit to control bipolar power output. The control signal may then communicated along an electrically conductive pathway to electrical contact J23. As shown in FIG. 5, electrical contact J23 may be coupled to the proximal end of insulated wire conductor 142 of electrical cord 40. As shown in FIG. 12, the distal end of insulated wire conductor 142 may be coupled to a radio-frequency power hand-switch activation assembly 146 within hand-piece 12. Hand-switch assembly 146 may comprise push button 148 which overlies a single pole, single throw, domed switch 150 on a platform comprising a printed circuit board, with the construction and wiring of the hand-switch assembly 146 known in the art. Upon depression of push button 148, the domed switch 150 beneath push button 148 forms a closed circuit which enables the control signal, here comprising a relatively low voltage direct current, to return and be sensed by electro surgical unit 300, generally via wire conductor 142, which then accordingly provides bipolar power. When the button 148 is released, the control circuit opens and the electro surgical unit 300 no longer receives the control signal to activate radio-frequency power. Consequently, the electro surgical unit 300 then deactivates the bipolar radio-frequency power output.

A control signal from electro surgical unit 300 may be provided to electrical contact J15, which is configured to receive a control signal from electrosurgical unit 300 as part of a control circuit to control monopolar power output. The control signal may then communicated along an electrically conductive pathway to electrical contact J24. While not shown in FIG. 5, electrical contact J24 may be coupled to the proximal end of insulated wire conductor 144 of electrical cord 40. As shown in FIG. 12, the distal end of insulated wire conductor 144 may be coupled to a radio-frequency power hand-switch activation assembly 152 within hand-piece 12. Hand-switch assembly 152 may comprise push button 154 which overlies a single pole, single throw, domed switch 156, which may comprise beryllium copper, on a platform comprising a printed circuit board, with the construction and wiring of the hand-switch assembly 152 known in the art. Upon depression of push button 154, the domed switch 156 beneath push button 154 forms a closed circuit which enables the control signal, here comprising a relatively low voltage direct current, to return and be sensed by electro surgical unit 300, generally via wire conductor 144, which then accordingly provides monopolar power. When the button 154 is released, the control circuit opens and the electrosurgical unit 300 no longer receives the control signal to activate radio-frequency power. Consequently, the electrosurgical unit 300 then deactivates the monopolar radio-frequency power output.

Exemplary hand switch assemblies may be found in U.S. Publication No. 2006/0149225, published Jul. 6, 2006, and U.S. Publication No. 2005/0090816, published Apr. 28, 2005, which are assigned to the assignee of the present invention and are hereby incorporated by reference in their entireties to the extent they are consistent.

In certain situations, during monopolar operation of device 10, electrode 180 b may be undesirably energized due to capacitive coupling. In this case, monopolar radio-frequency energy traveling from electro surgical unit 300 along wire conductor 130 a to electrode 180 a may also be transferred to wire conductor 130 b and ultimately to electrode 180 b by capacitive coupling. In a situation where electrical cord 40 is approximately 10 feet long, and hand-piece 12 is approximately 8 inches long, radio-frequency monopolar energy may be transferred via capacitive coupling over a distance of almost 11 feet of device 10.

A solution to capacitive coupling may be to separate the parallel wire conductors 130 a, 130 b along their entire length by a suitable distance. However, a suitable distance, for the radio-frequency power levels being considered, would add significant width or diameter to cord 40, and become cumbersome for the user.

Another solution to capacitive coupling may be to introduce an electrical break or interruption in wire conductor 130 b to effectively decrease the length of wire conductor 130 b along which the transfer of radio-frequency energy to electrode 180 b via capacitive coupling may take place. To this end, as shown in FIG. 12b , hand-switch assembly 146 to activate bipolar power is now in direct electrical communication with wire conductor 130 b and electrode 180 b. Also as shown, switch 150 of hand-switch assembly 146 as been replaced and hand-switch assembly 146 now comprises a double pole, single throw momentary switch 160 which is in series between electrode 180 b and a bipolar power output of electro surgical unit 300 to be coupled to the device 10.

In the foregoing manner, during monopolar operation of device 10, radio-frequency energy traveling from electrosurgical unit 300 along wire conductor 130 a to electrode 180 a which may be transferred to wire conductor 130 b by capacitive coupling can no longer travel to electrode 180 b given pole 162 of double pole, single throw switch 160 is in the open position. Thus, any transfer of radio-frequency energy traveling from electro surgical unit 300 along wire conductor 130 a to electrode 180 a which may be transferred to electrode 180 b by capacitive coupling may only occur through the portion of the electrical circuit distal to pole 162.

Now, with regards to bipolar operation of device 10, as noted above hand-switch assembly 146 comprises push button 148 which overlies double pole, single throw switch 160 to activate and deactivate bipolar power to the first and second electrodes 180 a, 180 b. Upon depression of push button 148, the double pole, single throw switch 160 beneath push button 148 simultaneously closes and connects two circuits. First, pole 162, initially in an open circuit position, is now placed in a closed and connected circuit position such that the bipolar radio-frequency energy may now be provided to electrode 180 b. Additionally, pole 164, also initially in an open circuit position, is now also placed in a closed and connected circuit position to provide a control circuit which enables the control signal, here comprising a relatively low voltage direct current, to return and be sensed by electrosurgical unit 300, generally via wire conductor 142, which then accordingly activates bipolar power. When the button 148 is released, both poles 162, 164 return to their initial opened positioned and the control circuit disconnects and the electro surgical unit 300 no longer receives the control signal and deactivates radio-frequency power. Consequently, the electrosurgical unit 300 then deactivates the bipolar radio-frequency power output. Furthermore, the circuit to electrode 180 b also opens, thus inhibiting electrode 180 b from receiving monopolar radio-frequency energy during the operation of device 10 in this manner. In this embodiment, the double pole, single throw switch 160 may be provided by two dome switches in overlapping arrangement on opposing sides of a cantilevered printed circuit board. In this manner, push button 148 may act directly upon one of the dome switches, causing the switch to close to form a closed circuit. Push button 148 may also cause the cantilevered printed circuit board to rotate and move the opposing dome switch thereon into contact with a mechanical stop which causes the second dome also to close to form a closed circuit.

In yet another embodiment, as shown in FIG. 12c , switch 156 of hand-switch assembly 152 has been replaced with switch 168 and includes bias spring 170, which may be a leaf-spring. As shown, when in a first position, switch 168 is in position to deactivate the monopolar power to electrode 180 a of device 10 from electro surgical unit 300 as the control circuit for monopolar power is now open, and connect electrode 180 b with bipolar power output of electro surgical unit 300. In this manner, when switch 150 is depressed, bipolar power may be provided to electrodes 180 a, 180 b. After switch 150 is released, switch 168 may be depressed, against the bias of spring 170, to activate monopolar power to electrode 180 a, as well as inhibit capacitive coupling of electrode 180 b to the monopolar power by disconnecting electrode 180 b from conductor 130 b. When switch 168 is released monopolar power is deactivated and spring 170 returns switch 168 to its initial position.

Electrosurgical unit 300 may also be configured to receive a stream of serial data including certain operating parameters and other information from device 10 concerning the set-up and use of device 10. In particular, as shown in FIG. 5, printed circuit board 24 may include an electronic memory 26 (also shown at U1 in FIG. 7), and more particularly an electrically erasable programmable read only memory (EEPROM) in which to store such operating parameters and other information.

For example, memory 26 may include a unique identifier (e.g. model number and serial number) and a fixed time period for use of device 10 (e.g. 24 hours) from the time of first radio-frequency activation which is then stored by electro surgical unit 300 for future reference. Memory 26 may include at least one operating parameter such as default settings for radio-frequency power level and fluid flow level for device 10, as discussed in greater detail below. Memory 26 may include settings for a range of radio-frequency power levels and fluid flow levels for device 10, which extend from a minimum radio-frequency power level and minimum fluid flow level to a maximum radio-frequency power level and maximum fluid flow level for device 10. Memory 26 may also include operating parameters such as one or more relationships which relate fluid flow level to the radio-frequency power level over a range of fluid flow levels and radio-frequency power levels for device 10. As shown in FIG. 7, data is received by electrosurgical unit 300 from memory 26 via electrical contacts J1 to J4.

Printed circuit board 24 also may include electrical contacts J12 and J13 which are configured to detect moisture or wetness on printed circuit board 24. Contacts J12 and J13 are configured to be part of a moisture monitoring circuit provided with a predetermined impedance. If the impedance between the contacts J12 and J13 decreases, such as may occur if fluid 502 where to form a bridge between the contacts thus electrically coupling the contacts, electrosurgical unit 300 may cease operation until the predetermined impedance value is attained.

Cartridge member 18, and in particular printed circuit board 24, also may include electrical contacts which are configured to receive power for additional features and accessories of device 10 including, for example a light, such as a light emitting diode (LED) or fiber optic light, to illuminate a tissue treatment site during a surgical procedure. The LED may require a relatively low power, such as a magnitude of 4-5 volts DC (direct current).

Cartridge member 18, and in particular printed circuit board 24 may also include electrical contacts which are configured to provide connection and transmit signals to a video recording source to record video, for example, of a tissue treatment site during a surgical procedure, which may be viewed by a video camera, such as a digital or fiber optic video camera, provided with device 10.

Having discussed the electrical and fluid communication of device 10 with electrosurgical unit 300 and fluid source 500, attention will now be directed to end effector of device 10 used for the treatment of tissue.

As previously discussed, the distal end of insulated wire conductors 130 a, 130 b are coupled to a proximal portion of shafts 124 a, 124 b of shaft member assembly 128 within hand-piece 12. Now, referring to FIG. 13, shaft member assembly 128 comprises two parallel, self-supporting, electrically conductive hollow shafts 124 a, 124 b, which comprise metal such as stainless steel tubing. Carried by and connected to the distal ends of shafts 124 a, 124 b are two laterally and spatially separated (by empty space) stationary contact elements comprising electrodes 180 a, 180 b which may be configured as mirror images in size and shape, and have a blunt distal end with a surface devoid of edges (to provide a uniform current density) to treat tissue. In the present embodiment electrodes 180 a, 180 b comprise an electrically conductive metal, such as stainless steel. Other suitable materials may include titanium, gold, silver and platinum.

In certain embodiments, one or both shafts 124 a, 124 b may be made of electrically non-conducting material except for the portion at the distal end that comes in contact with electrodes 180 a, 180 b. In these embodiment, an insulated wire conductor would extend and be joined to the electrically conducting portion of shaft 124 a, 124 b. In still other embodiments, shafts 124 a, 124 b may completely comprise electrically non-conducting material, in which case an insulated wire conductor would extend and be joined directly to electrodes 180 a, 180 b.

As shown in FIG. 13, each electrode 180 a, 180 b comprises an elongated portion 182 a, 182 b. With respect to length, in the present embodiment, elongated portion 182 a, 182 b has a length in the range of and any increment between 2 mm to 6 mm, and more specifically have a length of in the range of and any increment between 3 mm to 5 mm. With respect to spacing, in the present embodiment the spatial gap separation GS between electrodes 180 a, 180 b in the range of and any increment between 0.1 mm to 4 mm, and more specifically in the range of and any increment between 1 mm to 2.5 mm, and more specifically in the range of and any increment between 1.5 mm to 2.3 mm.

As best shown in FIG. 14, opposing concave sides 192 a 1194 a of elongated portion 182 a, and opposing concave sides 192 b 1194 b of elongated portion 182 b converge laterally to provide a wedge shaped blade portion 196 a, 196 b which terminates in a lateral cutting edge 198 a, 198 b which extends longitudinally along a length of each electrode 180 a, 180 b. As shown in FIG. 13, lateral cutting edge 198 a, 198 b transitions smoothly onto the distal end of each electrode 180 a, 180 b and forms a portion of the distal end of each electrode 180 a, 180 b.

Lateral cutting edge 198 a, 198 b may be configured to cut tissue electro surgically in the presence of monopolar radio frequency energy from electro surgical unit 300, without any fluid 502 being provided from fluid source 500. However, in other embodiments, lateral cutting edge 198 a, 198 b may be configured to cut tissue with fluid 502 being provided simultaneously from device 10, or be configured to cut tissue mechanically without electro surgical energy. Furthermore, while two cutting edges 198 a, 1988 b are shown, only one of the edges 198 a or 198 b may be configured to cut tissue electrosurgically or mechanically. In such instance, the blade portion of one electrode may be eliminated and the elongated portion may be completely cylindrical.

As shown in FIG. 13, electrodes 180 a, 180 b and elongated portions 182 a, 182 b terminate in distal end portion 186 a, 186 b. The distal end portion 186 a, 186 b of electrodes 180 a, 180 b are configured to move and slide with painting action across a tissue surface in the presence of bipolar radio frequency energy from electrosurgical unit 300 and fluid 502 from the fluid source 500. As shown, the distal end portion 186 a, 186 b of each electrode 180 a, 180 b has a blunt, rounded shape which provides a smooth contour surface. More specifically, as shown, distal end portion 186 a, 186 b of each electrode 180 a, 180 b comprises a spherical portion 190 a, 190 b. In the present embodiment, spherical portion 190 a, 190 b has a radius in the range of and any increment between 0.5 mm to 1.5 mm, and more specifically in the range of and any increment between 0.75 mm to 1.15 mm.

As best shown in FIGS. 14 and 15, within a cylindrical portion 184 a, 184 b of each electrode 180 a, 180 b proximal to distal end portion 186 a, 186 b, each electrode 180 a, 180 b includes a longitudinally oriented linear blind bore 200 a, 200 b and counter bore 202 a, 202 b. As shown in FIG. 15, the outside diameter of a distal end portion of each shaft 124 a, 124 b may be configured to extend into counter bore 202 a, 202 b of electrodes 180 a, 180 b and fit with the diameter of counter bore 202 a, 202 b, with the distal end of each shaft 124 a, 124 b in contact with the bottom of the counter bore. The electrodes 180 a, 180 b and shafts 124 a, 124 b may then be welded together. In alternative embodiments, the outside diameter of shafts 124 a, 124 b may be configured to fit with the diameter of counter bore 202 a, 202 b to form a press (interference) fit to provide a secure connection. In other alternative embodiments, electrodes 180 a, 180 b may be assembled to shafts 124 a, 124 b by threaded engagement. In still other embodiments, electrodes 180 a, 180 b may be detachably assembled to shafts 124 a, 124 b such that they may be removed from the shafts 124 a, 124 b, preferably manually by human hand.

In addition to blind bore 200 a, 200 b and counterbore 202 a, 202 b, as shown in FIG. 14, electrodes 180 a, 180 b also include a through bores 204 a 1206 a and 204 b 1206 b which perpendicularly intersects bore 200 a, 200 b and perpendicularly intersect one another to provide outlets 208 a 1210 a 1212 a 1214 a and 208 b/210 b/212 b 1214 b for fluid 502. Thus, after fluid 502 flows through the lumens 126 a, 126 b of shafts 124 a, 124 b, fluid 502 then flows through into the tubular passage provided by blind bore 200 a, 200 b and then into the tubular passage provided by through bores 204 a 1206 a and 204 b/206 b where it thereafter exits device 10 from fluid outlets 208 a 1210 a 1212 a 1214 a and 208 b/210 b 1212 bI214 b, which are all proximal to distal end portion 186 a, 186 b of electrodes 180 a, 180 b. As shown in FIG. 14, fluid outlets 208 a 1212 a and 208 b/212 b are defined by the cylindrical portion 184 a, 184 b of electrodes 180 a, 180 b, while fluid outlets 210 a 11214 a and 210 b 1214 b are defined by sides of 192 a 1194 a and 192 b 1194 b of blade portion 196 a, 196 b and adjacent cutting edge 198 a, 198 b.

As best shown in FIGS. 13 and 15, a portion of the lengths of shafts 124 a, 124 b are surrounded by and encapsulated in a common outer member 216, which may comprise a flexible plastic material. Outer member 216 electrically insulates the exposed length of shafts 124 a, 124 b.

Outer member 216 may be formed by injection molding. During the injection molding process, a sub-assembly comprising electrodes 180 a, 180 b and shafts 124 a, 124 b may be placed in an injection mold prior to the introduction of the plastic material. Thereafter, the mold may be closed and a thermoplastic may be injected into the unoccupied portions of the mold cavity to overmold and mold-in place portions of the sub-assembly as shown in FIG. 13. During the injection molding process, retainer clips (not shown) may provide the benefit of retaining shafts 124 a, 124 b in position relative to each other to better ensure that the shafts 124 a, 124 b are centrally located within the polymer molding.

To be hand shapeable by surgeons and other users of device 10, so that the device 10 may be used in a greater multitude of angles and locations, at least a portion of shafts 124 a, 124 b of device 10 may be malleable to provide a malleable shaft member assembly 128. Also, in this manner, a distal portion of shafts 124 a, 124 b may be bendable at an angle relative to the longitudinal axis of the proximal portion of shafts 124 a, 124 b during manufacturing of device 10 so they may be provided to users of device 10 at various angles. For example, angle may range from 5 degrees to 90 degrees, and more specifically, 15 degrees to 45 degrees, and even more specifically 30 degrees. As used herein, malleable means able to be shaped, particularly by bending (without a mechanical mechanism, such as a hinge or joint). It should be understood that shaft member assembly 128 may independently maintain the shape associated with the selected bent shape, and does not require additional components (e.g., pull wires, etc.) to maintain the selected bent shape. Furthermore, shaft member assembly 128 may maintain the selected, shape such that when device 10 is used to treat tissue, and will not overtly deflect from the selected shape. Furthermore, shaft member assembly 128 may be constructed such that a user can readily re-shape the shafts back to a straight state and/or other desired bent configurations.

Outer member 216, in addition to electrically insulating shafts 124 a, 124 b from one another, has been found to be particularly useful in facilitating the hand shaping of shafts 124 a, 124 b of shaft member assembly 128 simultaneously and with a similar contour without cracking and maintaining the tip spacing. In this manner, surgeons and other users of device 10 need not bend the shafts 124 a, 124 b individually.

To provide malleability, shafts 124 a, 124 b preferably have an outer wall diameter of about 0.063 inches and an inner wall diameter of about 0.032 inches. Shafts 124 a, 124 b also preferably are made from 304 stainless steel with a temper from about ½ to ¾hard, 130,000 to 150,000 psi. (pounds per square inch) tensile strength) and an elongation at break of about 40%. Shafts 124 a, 124 b with the foregoing properties provide sufficient stiffness as not to be too pliable during normal use of device 10, while at the same time inhibiting the shafts 124 a, 124 b from kinking or breaking when shaped for application. When the wall thickness may be too thin, shafts 124 a, 124 b may kink, and when the wall thickness may be too thick, the shafts 124 a, 124 b may be too stiff. Furthermore, a shaft 124 a, 124 b b with a larger diameter may also kink more than a shaft of smaller diameter. Shafts 124 a, 124 b may also be malleable for a portion of the length or full length depending on application. For example, the shafts 124 a, 124 b can be made with variable stiffness along the length and be malleable only for a distal portion thereof. This may be performed by controlled annealing of the shafts 124 a, 124 b only in the area where malleability may be desired.

Another embodiment of device 10 is shown in FIGS. 16a-16g which shows an alternative hand-piece 12 a. In comparison to hand-piece 12, the electrodes 180 a, 180 b shown with hand-piece 12 a are narrower with less mass as to provide a narrower incision when cutting tissue, making the device less obtrusive, and also enhancing visibility.

As best shown in FIG. 16b and FIG. 16c , each elongated portion I82 a, I82 b of electrodes I80 a, I80 b still may comprise a blade portion and have a lateral edge configured and arranged to operate in similar fashion to the previous embodiment. However, unlike the electrodes I80 a, I80 b of FIG. 13, the cylindrical portion I84 a, 184 b has been eliminated. The elongated portion I82 a, I82 b provides a blade shaped member with an elongated substantially planar body having a length significantly greater than its width, and a width significantly greater than its thickness. Here, for example, the length may be in the range of and any increment between 6 mm to 15 mm, the width may be in the range of and any increment between 2 mm to 3 mm, and the thickness may be in the range of and any increment between 0.25 mm to 0.75 mm. With respect to spacing, in the present embodiment the spatial gap separation GS between the electrodes I80 a, I80 b is the same as for the previous embodiment. As shown, to provide a self-supporting single layer construction, each electrode 180 a, 180 b may be formed from planar metal in the form of a metal strip and, more specifically, sheet metal which may be formed by stamping or otherwise formed using a stamping die or other forming die.

As best shown in FIG. 16d , each elongated portion 182 a, 182 b comprises opposing sides 220 a/222 a, 220 b/222 b ; a medial edge 224 a, 224 b and a lateral edge 226 a, 226 b. To better clarify orientation, the thickness T of each elongated portion 182 a, 182 b is shown to separate sides 220 a, 220 b from sides 222 a, 222 b, while the width W of each elongated portion I82 a, 182 b is shown to separate the medial edges 224 a, 224 b from the lateral edges 226 a, 226 b.

Lateral edge 226 a, 226 b may further include a bevel on either or both sides thereof to provide a single or double bevel lateral edge, respectively. As shown, elongated portion I82 a includes a bevel 227 a, 229 a on each side 220 a, 222 a, respectively, to provide double bevel edge 226 a. Similarly, elongated portion 182 b includes a bevel 227 b, 229 b on each side 220 b, 222 b, respectively, to provide double bevel edge 226 b.

Lateral edge 226 a, 226 b, as well as distal end 228 a, 228 b may be configured to cut tissue electro surgically in the presence of monopolar radio frequency energy from electro surgical unit 300, without any fluid 502 being provided from fluid source 500. However, in other embodiments, lateral cutting edge 226 a, 226 b may be configured to cut tissue with fluid 502 being provided simultaneously from device 10, or be configured to cut tissue mechanically without electrosurgical energy. Furthermore, while two cutting edges 226 a, 226 b are shown, only one of the edges 226 a or 226 b may be configured to cut tissue electro surgically or mechanically.

Medial edges 224 a, 224 b are also shown to include a bevel on both sides thereof to provide a double bevel medial edge. However, unlike double bevel lateral edge 226 a, 226 b, double bevel medial edge 224 a, 224 b is not intended to be used to cut tissue and the double bevel exists predominately as a result of electrodes 180 a, 180 b being interchangeable for ease of manufacturing.

Referring back to FIGS. 16b and 16c , each electrode 180 a, 180 b is shown to have a distal (terminal) end 228 a, 228 b which is rounded, particularly from each medial edge 224 a, 224 b to the lateral edge 226 a, 226 b of the elongated portion 182 a, 182 b of each electrode 180 a, 180 b. More particularly, each rounded distal end 228 a, 228 b may be defined by a uniform radius. In this manner, the distal end of the device is void of sharp comers which could inadvertently snag, pierce or otherwise damage tissue.

As best shown in FIGS. 16e and 16f , each electrode 180 a, 180 b (only electrode 180 a is shown, electrode 180 b is similar) may further include a distal portion 230 a, 230 b which is at an obtuse angle A relative to side 220 a, 220 b and proximal portion 232 a, 232 b, with the obtuse angle A having a vertex which extends across the width of each electrode 180 a, 180 b. In this manner, each electrode 180 a, 180 b may have the general shape of a ski tip. In certain embodiments, the obtuse angle A may be in a range of and any increment between 91 degrees to 179 degrees and more particularly in a range of and any increment between 120 degrees to 175 degrees and even more particularly in a range of and any increment between 145 degrees to 170 degrees (e.g. 165 degrees). In this manner, the electrodes 180 a, 180 b are better configured to move across tissue during the treatment thereof as described in greater detail below. In various embodiments, the electrodes 180 a, 180 b may be malleable (e.g. made from Y4 to % hard stainless steel) to better facilitate bending of electrodes 180 a, 108 b to change the obtuse angle.

As best shown in FIGS. 16f and 16g , the distal portion 230 a, 230 b of each electrode 180 a, 180 b may further include a protrusion 234 a, 234 b located on side 222 a 222 b, which is opposite the side 220 a, 220 b of the obtuse angle, but on the same side as outlets 240 a, 240 b described in greater below. Stated another way, protrusion 234 a, 234 b is located on side 222 a 222 b of distal portion 230 a, 230 b which is at a reflex angle B relative to proximal portion 232 a, 232 b. Here, the reflex angle B may be in the range of and any increment between 181 degrees to 269 degrees, and may be calculated by subtracting the value of the obtuse angle A from 360 degrees.

As show, each protrusion 234 a, 234 b here comprises a convex curvature, shaped like a circular dimple, which provides a blunt, rounded shape which provides a smooth contour surface. In the present embodiment, the convex curvature has a diameter in the range of and any increment between 0.5 mm to 1.5 mm, and more specifically in the range of and any increment between 0.75 mm to 1.15 mm. Protrusion 234 a, 234 b may be formed by stamping or otherwise forming a recess 236 a, 236 b, here a concave curvature, in distal portion 230 a, 230 b on side 220 a, 220 b using a stamping die or other forming die.

As discussed in greater detail below, protrusions 234 a, 234 b of electrodes 180 a, 180 b may be used to move and slide electrodes 180 a, 180 b with painting action across a tissue surface in the presence of bipolar radio frequency energy from electro surgical unit 300 and fluid 502 from the fluid source 500, while, at the same time functioning as standoffs to separate lateral edges 226 a, 226 b from contacting the tissue surface and inhibit edges 226 a, 226 b from cutting the tissue when the device 10 is used in this orientation. In this orientation, sides 220 a, 220 b may be referred to as the upper sides relative to the tissue being treated while sides 222 a, 222 b may be referred to the lower sides.

In order to best facilitate use of the hand-piece 12 a in the foregoing manner, electrodes 180 a, 180 b are shown to be coplanar (i.e. a thickness of each electrode 180 a, 180 b is in a common plane). More particularly, at least a portion of at least one of the opposing sides 220 a/222 a of electrode 180 a is parallel and coplanar with opposing sides 220 b/222 b of electrode 180 b, respectively. Even more particularly, at least a portion of each side 220 a/222 a of electrode 180 a is parallel and coplanar with a corresponding side 220 b/222 b of electrode 180 b, respectively.

With regards attachment to shafts 124 a, 124 b of shaft member assembly 128, electrodes 180 a, 180 b include a semi-circular tab portion 238 a, 238 b which may be welded to the side of shafts 124 a, 124 b. As shown, tabs 238 a, 238 b are welded to shafts 124 a, 124 b such that electrodes 180 a, 180 b extend distally from shafts 124 a, 124 b and fluid from the lumens 126 a, 126 b is expelled from fluid outlets 240 a, 240 b located at the distal end of shafts 124 a, 124 b and adjacent the electrodes 180 a, 180 b on the same side as protrusions 234 a, 234 b.

In alternative embodiments, electrodes 180 a, 180 b and shafts 124 a, 124 b may be unitary and continuous. In other words, may be formed from a single piece of metal which is uninterrupted. For example, the metal used to provide electrodes 180 a, 180 b, such as planar metal which may be in the form of a metal strip (such as sheet metal), may include a proximal portion which may be formed into the shape of a tube, as shown in FIG. 16h (only electrode 180 a shown, electrode 180 b similar), such as by roll forming, and thereafter welded along the longitudinal seam 242 a to provide a sealed tube. Alternatively, a distal end portion of the metal shafts 124 a, 124 b, such as stainless steel tubes, may be flattened and shaped to provide the form and function of electrodes 180 a, 180 b as shown in FIG. 16i (only electrode 180 a shown, electrode 180 b similar). In this manner, an opening would also be provided in the side wall of shafts 124 a, 124 b adjacent the flattened portion to provide fluid outlets 240 a, 240 b.

Also in alternative embodiments, fluid outlets 240 a, 240 b may be located on the opposite side of protrusions 234 a, 234 b, as shown in FIG. 16j (only electrode 180 a shown, electrode 180 b similar). In this manner, fluid from fluid outlets 240 a, 240 b may flow distally on surfaces 220 a, 220 b to recesses 236 a, 236 b. Thereafter, once recesses 236 a, 236 b are filled with fluid, the fluid may overflow the recesses 236 a, 236 b and flow out of the recesses to protrusions 234 a, 234 b. In yet another alternative embodiment, electrodes 180 a, 180 b may be positioned relative to the fluid outlets 240 a, 240 b such that fluid outlets 240 a, 240 b are located on both sides 220 a, 220 b and 222 a, 222 b as shown in FIG. 16k (only electrode 180 a shown, electrode 180 b similar).

Also in alternative embodiments, fluid outlets 240 a, 240 b may be eliminated and a single fluid outlet 240 may be provided between electrodes 180 a, 180 b as shown in FIG. 161.

Having discussed electro surgical device 10 in detail, attention will now be directed to electrosurgical unit 300 shown starting at FIG. 17a . As shown in FIGS. 17a and 17b , electrosurgical unit 300 includes a front control panel 302. Front control panel 302 includes a power (on/off) switch 304 and touchscreen graphical user interface (GUI) 306. Front panel 302 also includes a ground pad receptacle 308 as well as a cartridge receptacle 310 configured to receive cartridge member 18 of cartridge assembly 16, which is shown installed in FIG. 17b .

As shown in FIG. 18, electro surgical unit 300 includes an AC power supply 320, radio-frequency power source/generator 322, controller 338, including a central processing unit (CPU) and memory, and cartridge docking assembly 340 all interconnected and designed to communicate and function as an electro surgical unit which provides radio-frequency power in a manner known in the art.

As shown in FIG. 19, electrosurgical unit 300 includes a docking assembly 340 with cartridge member 18 placed between upper receptacle enclosure 348 and lower receptacle enclosure 350. Front, right side, left side, rear and top views of the docking assembly 340 with a moveable docking mechanism 410 in the up (non-use) position prior to engaging with cartridge member 18 are shown in FIGS. 20-24, respectively. Operation of the docking assembly 340 will now be discussed in greater detail, with FIGS. 20-24 presented as needed.

Referring to FIG. 25, upper receptacle enclosure 348 and lower receptacle enclosure 350 have been hidden to better show the operation of docking assembly 340. As shown in FIG. 25, near the end of insertion of cartridge member 18, the distal end 22 of cartridge member 18 first interacts with engagement mechanism 342, which is to inhibit the cartridge member 18 from inadvertently sliding out of receptacle 310 and separating from electrosurgical unit 300, as well as releaseably engage the cartridge member 18 when sufficient removal force may be applied to the engagement mechanism 342 to disengaged the cartridge member 18 and retract it from receptacle 310.

As shown, the engagement mechanism 342 comprises a spring loaded ball 344 which may enter a detent 34 (shown in FIG. 3) which may be provided as part of the lower cartridge enclosure 350 (not shown). Engagement mechanism 342 acts to hold the cartridge member 18 in a temporary fixed use position relative to the electrosurgical unit 300. As the cartridge member 18 is inserted into receptacle 342, the lower surface of cartridge body 20 b slides over the spring loaded ball 344 with a sufficient insertion force to overcome the bias/compression force of the spring 346 and retract the ball 344. As the cartridge member 18 thereafter reaches its use position, the ball 344 enters a detent 34 formed in cartridge body 20 b (shown in FIG. 3) which, under the force of compressed spring 346, now acts to hold the cartridge member 18 and electrosurgical unit 300 at their relative positions. Furthermore, the engagement mechanism 342 provides the user with tactile feedback that the cartridge member 18 has been properly received by electro surgical unit 300. Alternately, after ejection may be selected and a removal force is applied to cartridge member 18 sufficient to overcome the retention force applied by the spring 346, the spring 346 may again be compressed and the ball 344 removed from the detent 34 to facilitate removal of the cartridge member 18 from the electrosurgical unit 300.

As the ball 344 enters detent 34, the distal end 22 of cartridge member 18 now makes contact with a two position contact switch 354 which, when cartridge member 18 is absent, is in the open position. As cartridge member 18 is more fully inserted into cartridge receptacle 310 with an insertion force sufficient to close switch 354, an electrical circuit in the electrosurgical unit 300 may be closed which provides a signal to a controller 338 within electro surgical unit 300 that a cartridge member 18 has been fully inserted into cartridge receptacle 310. Upon receipt of the signal that a cartridge member 18 has been fully inserted into the cartridge receptacle 310, electro surgical unit 300 may now energize a solenoid 356.

Referring now to FIG. 25 and FIG. 26, solenoid 356 retracts armature 358, which may be coupled to lever 360 by pull bar 362. Consequently, upon retraction of armature 358, lever 360 may be rotated about pivot 364 and lever portion 366 rotates downward from its non-use (unengaged) position, as shown in FIG. 25, to its use (engaged) position, as shown in FIG. 26. As lever portion 366 rotates downward, pin 368 enters cylindrical cavity 36 formed in cartridge body 20 a. Pin 368 performs multiple functions. First, pin 368 provides a locking mechanism to prevent inadvertent removal or dislodging of cartridge member 18 while electro surgical unit 300 is ready for operation. Pin 368 also provides a locating/positioning mechanism to further position cartridge member 18 relative to electro surgical unit 300 in addition to engagement mechanism 342.

Lever 360 may be pulled downward to its use (engaged) position with sufficient force to overcome the bias/compression force of spring 370, which thereafter returns lever 360 to its non-use position when power is removed from solenoid 356 and armature 358 is free to extend.

As lever 360 is rotated about pivot 364, lever portion 376, which is opposite lever portion 366, rotates upward about pivot 364. As shown in FIG. 27 and FIG. 28, lever portion 376 includes a catch 378 in the form of a notch into which locking pin 380 with roller 388 enter and are now captured as a result of the rotation of lever 360.

As a result of pin 380 and roller 388 entering catch 378 as shown in FIG. 28, lever 384 (shown in phantom in FIGS. 27 and 28), which rotates about pivot 386, may only travel rearward based on the length of catch 378. In other words, once pin roller 388 makes contact with the rearward surface 382 of catch 378, lever 384 may now be prevented from further rearward travel relative to lever 360 due to roller 388 contacting lever 384.

Returning to FIG. 26, once lever 360 is in its use position, an optical sensor then provides a signal to a controller within the electro surgical unit 300 that lever 360 is in such position. Upon receipt of the signal that lever 360 is now in its use position, electrosurgical unit 300 now activates electric motor 396 which turns shaft 398 via a gearbox 400. Shaft 398 provides an axle for cam 402 which, as a result of the rotation of shaft 398, contacts surface 404 of lever 384.

Upon rotation of cam 402 against surface 404 of lever 384, lever 384 may travel rearward until roller 388 makes contact with the rearward surface 382 of catch 378. As the position of lever 384 may now be fixed against moving rearwards by roller 388 fixated on contacting lever 384, surface 404 now provides a fixed load bearing surface against cam 402. As a result, upon further rotation of cam 402 against surface 404, movable docking mechanism 410 rotates downward and moves radially about pivot 412 (shown in FIG. 22) against the bias/tension force of spring 414 (shown in FIG. 23) until it reaches its use position as sensed by an optical sensor. Docking mechanism 410 is now in its use (engaged) position. In other words, ready to deliver radio-frequency power and fluid as designed. After use of electro surgical unit 300 is complete, a user may eject cartridge member 18 from unit 300 by selecting such control on unit 300, and the reverse of the docking procedure may be performed.

Should power be removed from solenoid 356 while docking mechanism 410 is in its use position, for instance if unit 300 is unplugged, electro surgical unit 300 may be configured to return docking mechanism 410 upward to its non-use position and allow cartridge member 18 to be removed. As indicated above, when power is removed from solenoid 356, armature 358 may be free to extend and lever portion 366 of lever 360 rotates upward about pivot 364 due to the force of spring 370 to remove pin 368 from cylindrical cavity 36 formed in cartridge body 20 a. Simultaneously, lever portion 376 of lever 360 rotates downward about pivot 364 to disengage locking pin 380 with roller 388 from catch 378. Upon the disengaging of locking pin 380 and roller 388 from catch 378, lever 384 may now be free to move rearward about pivot 386. The force of spring 414 then overcomes the force of spring 416 and moves lever 384 rearward, releasing cam 402 from acting on surface 404. As cam 402 releases from surface 404, docking mechanism 410 is rotated upwards about pivot 412 due to the force of spring 414. As docking mechanism 410 returns to its non-use position, and cam 402 rotates back to the not in use position, lever 384 moves forward about pivot 386 due to the force of spring 416. In this manner, locking pin 380 and roller 388 are now positioned to be received by catch 378.

Referring now to FIG. 29, FIG. 29 shows an exploded view of the cartridge member 18, upper receptacle enclosure 348, lower receptacle enclosure 350 and a fluid delivery apparatus 420. Fluid delivery apparatus 420 comprises a peristaltic pump assembly 422, and more specifically a rotary peristaltic pump assembly. As shown in FIG. 30, compression elements shown as pinch rollers 424 of pump head 434 rotate about shaft 426 which may be turned by motor 428. As shown, when assembly is in its use position, rollers 424 engage and compress pump tubing segment 78 in a known manner against opposing load bearing surface 430 of semi-circular shoe/base 432 to pump fluid 502 from the fluid source 500 to the hand-held device 10.

Fluid 502 may be conveyed by peristaltic pump assembly 422 by waves of contraction placed externally on the delivery tubing segment 78 which are produced mechanically by rotating pinch rollers 424 which rotate on drive shaft 426 and intermittently compress the delivery tubing segment 78 against support surface 430. Peristaltic pumps are generally preferred, as the electro-mechanical force mechanism, here rollers 424 driven by electric motor 428, does not make contact with the fluid 502, thus reducing the likelihood of inadvertent contamination.

Referring to FIG. 19 and FIG. 31, as docking mechanism 410 rotates downwards towards its use position, drive coupling 438 contacts radio-frequency power delivery apparatus 440 and pushes an electrical contact assembly 442 linearly downwards towards printed circuit board 24 of cartridge member 18 against the bias/compression force of spring 444. Conversely, upon docking mechanism 410 rotating upwards towards its non-use position, spring 444 raises electrical contact assembly 442 away from printed circuit board 24 and to its non-use position.

In the above manner, both power delivery apparatus 440 and fluid delivery apparatus 420 move simultaneously to save time as compared to if they were to move sequentially, as well jointly, thus requiring only one shared drive mechanism, here comprising motor 396, rather than two separate drive mechanisms.

As shown in FIG. 32 and FIG. 33, electrical contact assembly 442 extends through an aperture 452 in upper receptacle enclosure 348. As shown in FIG. 34 and FIG. 35, electrical contact assembly 442 comprises a plurality of electrical contacts 446 which extend through an electrical insulator/carrier 448.

As shown in FIG. 36, electrical contacts 446 are configured to mate and electrically communicate with the electrical contacts of printed circuit board 24, as well as the electric components and circuitry of electrosurgical unit 300 in a manner known in the art.

Electrical contacts 446 comprise a plurality of pogo (spring loaded) pins. As the pogo pins 446 make contact with printed circuit board 24, the pins 446 retract under load in a known manner until electrical insulator/contact carrier 448 may be positioned in contact with printed circuit board 24 and the pins 446 substantially retract into carrier 448. As shown in FIG. 36, an end portion of electrical contact carrier 448 may be configured to fit within aperture 32 of cartridge member 18.

Returning to FIG. 32, should electrical contact carrier 448 make contact with printed circuit board 24, radio-frequency power delivery apparatus 440 includes springs 450 which will compress upon reaching a load sufficient to overcome the bias/compression force of springs 450, with such force being lower than the force which may damage printed circuit board 24. In this manner, printed circuit board 24 may be protected from damage upon engagement with electrical contact assembly 442. Apparatus 440 also has the function of aligning contact carrier 448 to aperture 32 of cartridge member 18. In particular, the springs 450 and pins 454 (shown in phantom) are designed to allow the contact carrier 448 to float and align to the aperture 32 of cartridge member 18 as carrier 448 enters aperture 32, then return the contact carrier 448 to a straight position when retracted.

Having discussed electrosurgical unit 300 in detail, attention will now be directed to a system in which electro surgical device 10 and electro surgical unit 300 may be arranged and used, with FIG. 37 showing a view of one embodiment of a system of the present invention having exemplary electro surgical unit 300 in combination with a fluid source 500 and a handheld electro surgical device 10. FIG. 37 shows a movable cart 504 having a support member 506 comprising a hollow cylindrical post which carries a platform 508 comprising a pedestal table to provide a flat, stable surface for location of the electro surgical unit 300.

As shown, cart 504 further comprises a fluid source carrying pole 510 having a height which may be adjusted by sliding the carrying pole 510 up and down within the support member 506 and thereafter secured in position with a set screw. On the top of the fluid source carrying pole 510 is a cross support provided with loops at the ends thereof to provide a hook for carrying fluid source 500.

As shown in FIG. 37, fluid source 500 may comprise a bag of fluid from which the fluid 502 flows through drip chamber 48 after the bag is penetrated with a spike 50 located at the end of the drip chamber 48. In other embodiments, drip chamber 48 may be eliminated and tubing segment 46 may be attached directly to a spike 50. Thereafter, fluid 502 flows through flexible delivery tubing segment 46, cartridge member 18 and delivery tubing segment 106 of cable 42 to hand-piece 12 electro surgical device 10.

In the present embodiment the fluid 502 comprises saline solution, and even more specifically, normal (physiologic) saline. Although the description herein may make reference to saline as the fluid 502, other electrically conductive fluids can be used in accordance with the invention.

While an electrically conductive fluid having an electrically conductivity similar to normal saline is preferred, as will become more apparent with further reading of this specification, fluid 502 may also comprise an electrically non-conductive fluid. The use of a non-conductive fluid, while not providing all the advantage of an electrically conductive fluid, still provides certain advantages over the use of a dry electrode including, for example, reduced occurrence of tissue sticking to the electrodes 180 a, 180 b of device 10 and cooling of the electrodes and/or tissue. Therefore, it is also within the scope of the invention to include the use of a non-conducting fluid, such as, for example, deionized water.

As indicated above, electrosurgical unit 300 is configured to provide both monopolar and bipolar power output. However, electro surgical unit 300 preferably includes a lock out feature which prevents both monopolar and bipolar output from being activated simultaneously.

When the power switch 304 is turned on electro surgical unit 300, a number of touch control screens are presented to the user from the graphical user interface 306 to set up the use of device 10. As shown in FIG. 38, after performing an initial system check, a display 312 is presented to the user requesting insertion of cartridge member 18. Upon cartridge member 18 being placed in cartridge receptacle 310, controller 338 receives a signal of the presence thereof from a sensor. Controller 338 then initiates the movement of docking mechanism 410 from its non-use (unengaged) position to its use (engaged) position.

Upon reaching its use (engaged) position, controller 338 receives another signal to indicate such from another sensor. After receiving the signal, controller 338 now may access the memory 26 of cartridge member 18 for certain information stored thereon concerning device 10.

As indicated above, electro surgical unit 300 may be configured to receive and read a stream of serial data including certain process parameters and other information from device 10. Controller 338 may determine if memory 26 includes a unique identifier such as a serial number for device 10. If so, the controller 338 may read and store the serial number to its own memory. Controller 338 may also determine if a fixed time period (e.g. 24 hours) for use of device 10 is included in memory 26. If so, controller 338 may apply the time period to an internal countdown clock, which may begin counting the time period down after the first radio-frequency power activation of unit 300 with device 10 therein. Thereafter, once the time period has expired, controller 338 may be programmed to associate the serial number with an expired device 10 and no longer operate device 10. In this manner, use of device 10 with cartridge 18 may be limited as intended to a single use disposable to better assure patient safety.

As shown in FIG. 39, after electrosurgical unit 300 senses the insertion of cartridge member 18, a display 314 is presented to the user to confirm that that fluid source 500 has been spiked, and to initiate priming of electro surgical device 10 with fluid 502. Priming is desirable to inhibit radio-frequency power activation without the presence of fluid 502 in device 10.

After priming is complete, as shown in FIG. 40, display 316 is presented to the user indicating that the system is now ready for use. Additionally, display 316 presents the user with default radio-frequency power level settings 328 and 330 numerically in watts, which may be thereafter increased or decreased by touching radio-frequency power level selectors 332 a, 334 a and 332 b, 334 b, respectively. RF power output may be set in 1 watt increments in the range of 1 to 40 watts, 5 watt increments in the range of 40 to 100 watts and 10 watt increments in the range of 100 to 300 watts. When radio-frequency power is activated, the system ready portion of the display will change to visually indicate that radio-frequency power is active as shown in FIG. 41.

In addition to display 316 presenting a user with a default radio-frequency power level setting, display 316 also presents the user with a plurality of fluid flow settings 336 a, 336 b and 336 c, which correspond to fluid flow settings of low (represented by one fluid droplet), medium (represented by two fluid droplets) and high (represented by three fluid droplets), respectively. The appropriate setting will illuminate when selected to visual indication of such to the user, with the medium (or intermediate) setting generally being the default setting.

Controller 338 of electro surgical unit 300 may also be programmed to obtain and read the default settings for radio-frequency power level and fluid flow level for device 10 which may be stored in memory 26 and thereafter set the unit 300 to these settings and present these default settings on display 316.

Controller 338 of electrosurgical unit 300 may be programmed to obtain and read a maximum power level for use of device 10 which is stored in memory 26. In this manner, electro surgical unit 300 would not activate its radio-frequency power for device 10 should the user wish to select a radio-frequency power level greater than the maximum power level allotted.

Controller 338 of electrosurgical unit 300 may also be programmed to obtain and read data from memory 26 which relates a speed of the pump assembly 422, and therefore the throughput of fluid 502 expelled by fluid delivery apparatus 420, to a particular radio-frequency power level as well as a particular fluid flow setting. In this manner, the fluid flow from device 10 for a particular radio-frequency power level and fluid level may be better controlled and a greater power level would not be available for selection.

Exemplary functional relationships of fluid flow rate Q in units of cubic centimeters per minute (cc/min) on the Y-axis, and the bipolar RF power setting Ps in units of watts on the X-axis as shown in FIG. 42. The relationships may be engineered to inhibit undesirable effects such as tissue desiccation, electrode sticking, smoke production and char formation, while at the same time not providing a fluid flow rate Q at a corresponding RF power setting Ps which is so great as to provide too much electrical dispersion and cooling at the electrode/tissue interface. While not being bound to a particular theory, a more detailed discussion on how the fluid flow rate interacts with the radio frequency power, modes of heat transfer away from the tissue, fractional boiling of the fluid and various control strategies may be found in U.S. Publication No. 200110032002, published Oct. 18, 2001, assigned to the assignee of the present invention and hereby incorporated by reference in its entirety to the extent it is consistent.

As shown in FIG. 42, exemplary relationships QL, QM and QH are configured to increase the fluid flow rate Q linearly with an increasing radio-frequency power level setting Ps for each of three fluid flow rate settings of low, medium and high, respectively. Conversely, the relationships QL, QM and QH are configured to decrease the fluid flow rate Q linearly with a decrease RF power setting Ps for each of three fluid flow rate settings of low, medium and high, respectively. Accordingly, the data stored in the memory 26 of device 10 is to set a speed of the pump assembly 422 for a particular radio-frequency power level and a particular fluid flow level such that the throughput of fluid delivery apparatus 420 corresponds to the relationships provided in FIG. 42. The data may be stored in the form of equations, or as numerical data points as part of a database look-up table.

An exemplary bipolar radio-frequency power output curve of electrosurgical unit 300 is shown in FIG. 43. Impedance Z, shown in units of ohms on the X-axis and output power Po is shown in units of watts on the Y-axis. In the illustrated embodiment, the bipolar electrosurgical power (RF) is set to 300 watts. As shown in the figure, for an RF power setting Ps of 300 watts, the output power Po will remain constant with the set RF power Ps as long as the impedance Z stays between the low impedance cut-off of 30 ohms and the high impedance cut-off of 120 ohms. Below an impedance Z of 30 ohms, the output power Po will decrease as shown by the low impedance ramp. Above an impedance Z of 120 ohms, the output power Po will also decrease as shown by the high impedance ramp.

With respect to monopolar power output, an exemplary monopolar radio-frequency power output curve of electrosurgical unit 300 is shown in FIG. 44. Impedance Z, shown in units of ohms on the X-axis and output power Po is shown in units of watts on the Y-axis. In the illustrated embodiment, the bipolar electro surgical power (RF) is set to 300 watts. As shown in the figure, for an RF power setting Ps of 300 watts, the output power Po will remain constant with the set RF power Ps as long as the impedance Z stays between the low impedance cut-off of 200 ohms and the high impedance cut-off of 800 ohms. Below an impedance Z of 200 ohms, the output power Po will decrease as shown by the low impedance ramp.

Above an impedance Z of 800 ohms, the output power Po will also decrease as shown by the high impedance ramp.

Having discussed a system in which electrosurgical device 10 and electrosurgical unit 300 may be arranged and used, attention will now focus on an application of electro surgical device 10 to treating tissue. As shown in FIG. 45, one way in which device 10 with hand-piece 12 may be used is with the longitudinal axis of electrodes 180 a, 180 b vertically orientated, and the distal end portion 186 a, 186 b of electrodes 180 a, 180 b laterally spaced adjacent tissue surface 522 of tissue 520. When device 10 is used in this manner, electrodes 180 a, 180 b are connected to electrosurgical unit 300 and receive bipolar radio frequency power which forms an alternating current electrical field 528 in tissue 520 located between electrodes 180 a, 180 b. In the presence of alternating current, the electrodes 180 a, 180 b alternate polarity between positive and negative charges with current flow from the positive to negative charge. Without being bound to a particular theory, heating of the tissue is performed by electrical resistance heating.

Fluid 502, in addition to providing an electrical coupling between the device 10 and tissue 520, lubricates surface 522 of tissue 520 and facilitates the movement of electrodes 180 a, 180 b across surface 522 of tissue 520. During movement of electrodes 180 a, 180 b, electrodes 180 a, 180 b typically slide across the surface 522 of tissue 520. Typically the user of device 10 slides electrodes 180 a, 180 b across surface 522 of tissue 520 back and forth with a painting motion while using fluid 502 as, among other things, a lubricating coating. The thickness of the fluid 502 between the distal end portions 186 a, 186 b of electrodes 180 a, 180 b and surface 522 of tissue 520 at the outer edge of couplings 524 a, 524 b may be in the range of and any increment between 0.05 mm to 1.5 mm. Also, in certain embodiments, the distal end portion 186 a, 186 b of electrodes 180 a, 180 b may contact surface 522 of tissue 520 without any fluid 502 in between.

As shown in FIG. 45, fluid 502 expelled from fluid outlets 208 a/210 a/212 a/214 a and 208 b 1210 b/212 b 1214 b may form into droplets 526 a, 526 b which flow distally on electrodes 180 a, 180 b. As shown in FIG. 45, droplets 526 a, 526 b may form at varying times from fluid 502 expelled from anyone of the fluid outlets. Also, fluid 502 may be expelled in varying quantity from each of the fluid outlets, depending on, for example, device orientation, pressure, flow rate and varying fluid outlet sizes. With use of device 10, the size of droplets 526 a, 526 b may also vary due to changes in the surface finish of the electrodes 180 a, 180 b, for example, as a result of being contaminated by blood and tissue.

As shown in FIG. 45, fluid couplings 524 a, 524 b comprise discrete, localized webs and more specifically comprise triangular shaped webs or bead portions providing a film of fluid 502 between surface 522 of tissue 520 and electrodes 180 a, 180 b. When the user of electrosurgical device 10 places electrodes 180 a, 180 b at a tissue treatment site and moves electrodes 180 a, 180 b across the surface 522 of the tissue 520, fluid 502 is expelled from fluid outlets 208 a/210 a/212 a/214 a and 208 b 1210 b/212 b 1214 b around the surfaces of electrodes 180 a, 180 b and onto the surface 522 of the tissue 520 via couplings 524 a, 524 b. At the same time, radio-frequency electrical energy, shown by electrical field lines 528, is provided to tissue 520 at tissue surface 522 and below tissue surface 522 into tissue 520 through fluid couplings 524 a, 524 b. As shown in FIG. 46, hand-piece 12 of device 10 may be used to cut tissue by applying either cutting edge 198 a or 198 b to tissue 520, depending which electrode 180 a, 180 b is utilized.

With regards to hand-piece 12 a, as shown in FIG. 47, when the user of electro surgical device 10 places electrodes 180 a, 180 b at a tissue treatment site and moves electrodes 180 a, 180 b across the surface 522 of the tissue 520, fluid 502 is expelled from fluid outlets 240 a and 240 b onto surfaces 222 a, 222 b of electrodes 180 a, 180 b and onto the surface 522 of the tissue 520 via couplings 524 a, 524 b. At the same time, radio-frequency electrical energy, shown by electrical field lines 528, is provided to tissue 520 at tissue surface 522 and below tissue surface 522 into tissue 520 through fluid couplings 524 a, 524 b. In this manner, device 10 may be used to seal and/or shrink blood vessels in tissue 520 to inhibit blood loss therefrom. Similar to FIG. 46, hand-piece 12 a of device 10 may be used to cut tissue by applying either cutting edge 226 a or 226 b to tissue 520, depending which electrode 180 a, 180 b is utilized.

Device 10 may be used to perform a solid organ resection such as a liver resection. Edge 198 a or 198 b may be first used to score the outer capsule of the liver along the planned line of resection. Thereafter, the distal end portions 186 a, 186 b of electrodes 180 a, 180 b may be moved back and forth along the line, with radio frequency power and the flow of fluid on, resulting in coagulation of the liver parenchyma beneath the scored capsule. As the tissue is coagulated under and around the electrode surfaces, the electrodes 180 a, 180 b may be used to separate and blunt dissect the coagulated parenchyma and enter the resulting crevice. As the distal end portions 186 a, 186 b of electrodes 180 a, 180 b treat the parenchyma, the treated parenchyma looses integrity and becomes easier to separate, either alone or in conjunction with separation force applied by electrodes 180 a, 180 b from the user of the device.

Blunt dissection of the coagulated parenchyma IS performed by continuous abrading or splitting apart of the parenchyma with substantially the same back and forth motion as coagulation and with the device 10 being held substantially in the same orientation as for coagulation of the liver parenchyma. However, with blunt dissection, the surgeon typically applies more force to the tissue. In various embodiments, once the liver parenchyma is coagulated, blunt dissection may be performed with or without monopolar radio frequency power (i.e., on or off) and/or with or without the presence of fluid from device 10. Additionally or alternatively, the tissue on opposing sides of the line of resection may be placed into tension perpendicular to the line of resection to facilitate resection. Furthermore, resection may also be accomplished by sharp dissection with edge 198 a or 198 b of electrodes 180 a, 180 b. Thus, with device 10, a surgeon may perform a resection procedure in a number of different ways.

As the parenchyma is resected, blood vessels within the parenchyma may be uncovered which extend across or transverse the line of resection. Device 10 may be used to shrink and seal these vessels by heating and shrinking the collagen contained in the walls of the vessels thus decreasing the diameter of the lumen of these vessels. For vessels with a diameter too large to completely occlude the lumen, the vessels may tied with suture on each side of the line of resection and thereafter severed therebetween. If such vessels are not first uncovered by removing the surrounding parenchyma tissue and without being severed, they may bleed profusely and require much more time to stop the bleeding. Consequently, it may be desirable to avoid separation by sharp dissection in situations where large vessels are not first uncovered and exposed.

This technique can also be used on other parenchymal organs such as the pancreas, the kidney, and the lung. In addition, it may also be useful on muscle tissue and subcutaneous fat. Its use can also extend to tumors, cysts or other tissue masses found in the urological or gynecological areas. It would also enable the removal of highly vascularized tumors such as hemangiomas.

The devices disclosed herein are particularly useful as non-coaptive devices that provide cutting of tissue, as well as coagulation, hemostasis and sealing of tissue to inhibit blood and other fluid loss during surgery. In other words, grasping of the tissue is not necessary to shrink, coagulate, cut and seal tissue against blood loss, for example, by shrinking collagen and associated lumens of blood vessels (e.g., arteries, veins) to provided the desired hemostasis of the tissue. Furthermore, the control system of the electro surgical unit 300 is not necessarily dependent on tissue feedback such as temperature or impedance to operate. Thus, the control system of electrosurgical unit 300 may be open loop with respect to the tissue which simplifies use.

Device 10 disclosed herein are particularly useful to surgeons to achieve hemostasis after cutting through soft tissue, as part of hip or knee arthroplasty. The distal end portions 186 a, 186 b can be painted over the raw, oozing surface 522 of tissue 520 to seal the tissue 520 against bleeding, or focused on individual larger bleeding vessels to stop vessel bleeding. As part of the same or different procedure, device 10 is also useful to stop bleeding from the surface of cut bone, or osseous, tissue as part of any orthopaedic procedure that requires bone to be cut.

As is well known, bone, or osseous tissue, is a particular form of dense connective tissue consisting of bone cells (osteocytes) embedded in a matrix of calcified intercellular substance. Bone matrix mainly contains collagen fibers and the minerals calcium carbonate, calcium phosphate and hydroxyapatite. Among the many types of bone within the human body are compact bone and cancellous bone. Compact bone is hard, dense bone that forms the surface layers of bones and also the shafts of long bones. It is primarily made of haversian systems which are covered by the periosteum. Compact bone contains discrete nutrient canals through which blood vessels gain access to the haversian systems and the marrow cavity of long bones. For example, Volkmann's canals which are small canals found in compact bone through which blood vessels pass from the periosteum and connect with the blood vessels of haversian canals or the marrow cavity. Devices 30 a-30 e disclosed herein may be particularly useful to treat compact bone and to provide hemostasis and seal bleeding vessels (e.g. by shrinking to complete close) and other structures associated with Volkmann's canals and haversian systems.

In contrast to compact bone, cancellous bone is spongy bone and forms the bulk of the short, flat, and irregular bones and the ends of long bones. The network of osseous tissue that makes up the cancellous bone structure comprises many small trabeculae, partially enclosing many intercommunicating spaces filled with bone marrow. Consequently, due to their trabecular structure, cancellous bones are more amorphous than compact bones, and have many more channels with various blood cell precursors mixed with capillaries, venules and arterioles. Device 10 disclosed herein may be particularly useful to treat cancellous bone and to provide hemostasis and seal bleeding structures such as the above micro-vessels (i.e. capillaries, venulesand arterioles) in addition to veins and arteries. Device 10 may be particularly useful for use during orthopedic knee, hip, shoulder and spine procedures (e.g. arthroplasty).

During a knee replacement procedure, the condyle at the distal epiphysis of the femur and the tibial plateau at the proximal epiphysis of the tibia are often cut and made more planer with saw devices to ultimately provide a more suitable support structure for the femoral condylar prosthesis and tibial prosthesis attached thereto, respectively. The cutting of these long bones results in bleeding from the cancellous bone at each location. In order to seal and arrest the bleeding from the cancellous bone which has been exposed with the cutting of epiphysis of each long bone, bipolar device 10 may be utilized. Thereafter, the respective prostheses may be attached.

Turning to a hip replacement procedure, the head and neck of the femur at the proximal epiphysis of the femur may be removed, typically by cutting with a saw device, and the intertrochantic region of the femur may be made more planer to provide a more suitable support structure for the femoral stem prosthesis subsequently attached thereto. With respect to the hip, a ball reamer may be used to ream and enlarge the acetabulum of the innominate (hip) bone to accommodate the insertion of an acetabular cup prosthesis therein, which will provide the socket into which the head of the femoral stem prosthesis fits. The cutting of the femur and reaming of the hip bone typically results in bleeding from the cancellous bone at each location. In order to seal and arrest the bleeding from the cancellous bone which has been cut and exposed, device 10 may be utilized. Thereafter, as with the knee replacement, the respective prostheses may be attached.

Device 10 may be utilized for treatment of connective tissues, such as for shrinking intervertebral discs during spine surgery. Intervertebral discs are flexible pads of fibrocartilaginous tissue tightly fixed between the vertebrae of the spine. The discs comprise a flat, circular capsule roughly an inch in diameter and about 0.25 inch thick, made of a tough, fibrous outer membrane called the annulus fibrosus, surrounding an elastic core called the nucleus pulposus.

Under stress, it is possible for the nucleus pulposus to swell and herniate, pushing through a weak spot in the annulus fibrosus membrane of the disc and into the spinal canal. Consequently, all or part of the nucleus pulposus material may protrude through the weak spot, causing pressure against surrounding nerves which results in pain and immobility.

Device 10 may be utilized to shrink protruding and herniated intervertebral discs which, upon shrinking towards normal size, reduces the pressure on the surrounding nerves and relieves the pain and immobility. Device 10 may be applied via posterior spinal access under surgeon control for focal shrinking of the annulus fibrosus membrane.

Where an intervertebral disc cannot be repaired and must be removed as part of a discectomy, device 10 may be particularly useful to seal and arrest bleeding from the cancellous bone of opposing upper and lower vertebra surfaces (e.g. the cephalad surface of the vertebral body of a superior vertebra and the caudad surface of an inferior vertebra). Where the disc is removed from the front of the patient, for example, as part of an anterior, thoracic spine procedure, device 10 may also be particularly useful to seal and arrest bleeding from segmental vessels over the vertebral body.

Device 10 may be utilized to seal and arrest bleeding of epidural veins which bleed as a result of the removal of tissue around the dural membrane during, for example a laminectomy or other neurosurgical surgery. The epidural veins may start bleeding when the dura is retracted off of them as part of a decompression. Also during a laminectomy, device 10 may be used to seal and arrest bleeding from the vertebral arch and, in particular the lamina of the vertebral arch.

As established above, device 10 of the present invention may inhibit such undesirable effects of tissue desiccation, electrode sticking, char formation and smoke generation. The use of the disclosed devices can result in significantly lower blood loss during surgical procedures. Such a reduction in blood loss can reduce or eliminate the need for blood transfusions, and thus the cost and negative clinical consequences associated with blood transfusions, such as prolonged hospitalization.

While a preferred embodiment of the present invention has been described, it should be understood that various changes, adaptations and modifications can be made therein without departing from the spirit of the invention and the scope of the appended claims. The scope of the invention should, therefore, be determined not with reference to the above description, but instead should be determined with reference to the appended claims along with their full scope of equivalents. Furthermore, it should be understood that the appended claims do not necessarily comprise the broadest scope of the invention which the Applicant is entitled to claim, or the only manner(s) in which the invention may be claimed, or that all recited features are necessary.

While a preferred embodiment of the present invention has been described, it should be understood that various changes, adaptations and modifications can be made therein without departing from the spirit of the invention and the scope of the appended claims. The scope of the invention should, therefore, be determined not with reference to the above description, but instead should be determined with reference to the appended claims along with their full scope of equivalents. Furthermore, it should be understood that the appended claims do not necessarily comprise the broadest scope of the invention which the Applicant is entitled to claim, or the only manner(s) in which the invention may be claimed, or that all recited features are necessary.

While a preferred embodiment of the present invention has been described, it should be understood that various changes, adaptations and modifications can be made therein without departing from the spirit of the invention and the scope of the appended claims. The scope of the invention should, therefore, be determined not with reference to the above description, but instead should be determined with reference to the appended claims along with their full scope of equivalents. Furthermore, it should be understood that the appended claims do not necessarily comprise the broadest scope of the invention which the Applicant is entitled to claim, or the only manner(s) in which the invention may be claimed, or that all recited features are necessary.

It is to be appreciated that the Detailed Description section, and not the Summary and Abstract sections, is intended to be used to interpret the claims. The Summary and Abstract sections may set forth one or more but not all exemplary embodiments of the present invention as contemplated by the inventor(s), and thus, are not intended to limit the present invention and the appended claims in any way.

The present invention has been described above with the aid of functional building blocks illustrating the implementation of specified functions and relationships thereof. The boundaries of these functional building blocks have been arbitrarily defined herein for the convenience of the description. Alternate boundaries can be defined so long as the specified functions and relationships thereof are appropriately performed.

The foregoing description of the specific embodiments will so fully reveal the general nature of the invention that others can, by applying knowledge within the skill of the art, readily modify and/or adapt for various applications such specific embodiments, without undue experimentation, without departing from the general concept of the present invention. Therefore, such adaptations and modifications are intended to be within the meaning and range of equivalents of the disclosed embodiments, based on the teaching and guidance presented herein. It is to be understood that the phraseology or terminology herein is for the purpose of description and not of limitation, such that the terminology or phraseology of the present specification is to be interpreted by the skilled artisan in light of the teachings and guidance.

The breadth and scope of the present invention should not be limited by any of the above-described exemplary embodiments, but should be defined only in accordance with the following claims and their equivalents.

The claims in the instant application are different than those of the parent application or other related applications. The Applicant therefore rescinds any disclaimer of claim scope made in the parent application or any predecessor application in relation to the instant application. The Examiner is therefore advised that any such previous disclaimer and the cited references that it was made to avoid, may need to be revisited. Further, the Examiner is also reminded that any disclaimer made in the instant application should not be read into or against the parent application. 

1-20. (canceled)
 21. An electrosurgical system comprising: an electrosurgical device comprising a memory, a first electrode, a second electrode, and fluid delivery tubing having an outlet proximate at least one of the first electrode or the second electrode; and an electrosurgical unit comprising a graphical user interface (GUI) and a radio-frequency power generator configured to output monopolar radio-frequency power and bipolar radio frequency power, the electrosurgical unit coupled with the electrosurgical device so as to provide radio frequency power generated by the radio-frequency power generator to at least one of the first electrode or the second electrode, to provide fluid to the fluid delivery tubing, and to provide data to be stored in the memory, the data comprising at least one operating parameter of the electrosurgical device received by the electrosurgical unit via the GUI and related to a radio-frequency power level or a fluid flow level.
 22. The electrosurgical system of claim 21, wherein the at least one operating parameter comprises a default setting for at least one of the radio-frequency power level or the fluid flow level.
 23. The electrosurgical system of claim 21, wherein the at least one operating parameter comprises settings for a range of radio-frequency power levels or a range of fluid flow levels.
 24. The electrosurgical system of claim 23, wherein the range of radio-frequency power levels is defined by a minimum radio-frequency power level and a maximum radio-frequency power level, and the range of fluid flow levels is defined by a minimum fluid flow level and a maximum fluid flow level.
 25. The electrosurgical system of claim 21, wherein the at least one operating parameter comprises one or more relationships between the fluid flow level and the radio-frequency power level.
 26. The electrosurgical system of claim 21, wherein the electrosurgical unit is configured to receive and read a stream of serial data from the memory.
 27. The electrosurgical system of claim 26, wherein the stream of serial data comprises a unique identifier of the electrosurgical device.
 28. The electrosurgical system of claim 27, wherein the unique identifier comprises at least one of a model number or a serial number.
 29. The electrosurgical system of claim 27, wherein the stream of serial data comprises a fixed time period for use of the electrosurgical device.
 30. The electrosurgical system of claim 29, wherein the fixed time period is measured from a time of first radio-frequency power activation of the electrosurgical device.
 31. The electrosurgical system of claim 30, wherein the electrosurgical unit further comprises an electrosurgical unit memory and an internal countdown clock, and wherein the time of first radio-frequency activation of the electrosurgical device is stored in the electrosurgical unit memory and applied to the internal countdown clock.
 32. The electrosurgical system of claim 31, wherein the electrosurgical unit is configured to associate the unique identifier with an expired electrosurgical device in the electrosurgical unit memory upon expiration of the fixed time period as determined by the internal countdown clock.
 33. The electrosurgical system of claim 36, wherein the electrosurgical unit is configured to obtain a default setting from the stream of serial data received from the memory.
 34. The electrosurgical system of claim 31, wherein the GUI comprises a touchscreen.
 35. The electrosurgical system of claim 31, wherein the memory comprises an electrically erasable programmable read only memory (EEPROM).
 36. An electrosurgical system comprising: an electrosurgical device comprising a memory, a first electrode, a second electrode, and fluid delivery tubing having an outlet proximate at least one of the first electrode or the second electrode; and an electrosurgical unit comprising a radio-frequency power generator configured to output monopolar radio-frequency power and bipolar radio frequency power and a pump configured to control fluid flow in the fluid delivery tubing, the electrosurgical unit coupled with the electrosurgical device so as to simultaneously provide radio frequency power generated by the radio-frequency power generator to at least one of the first electrode or the second electrode and fluid pumped by the pump to the fluid delivery tubing, wherein the pump has a plurality of fluid flow settings, and a fluid flow at any of the plurality of fluid flow settings varies according to a level of radio-frequency power provided by the radio-frequency power generator.
 37. The electrosurgical system of claim 36, wherein the plurality of fluid flow settings comprise a low fluid flow setting, a medium fluid flow setting, and a high fluid flow setting.
 38. The electrosurgical system of claim 37, wherein a fluid flow rate at any one of the low, medium or high fluid flow settings increases linearly with an increasing level of radio-frequency power provided by the radio-frequency power generator to the first electrode and the second electrode.
 39. The electrosurgical system of claim 37, wherein a fluid flow rate at any one of the low, medium or high fluid flow settings decreases linearly with an decreasing level of radio-frequency power provided by the radio-frequency power generator to the first electrode and the second electrode.
 40. The electrosurgical system of claim 37, wherein the electrosurgical unit sets a speed of the pump based on which one of the lower, medium or high fluid flow settings is selected and a level of the radio frequency power provided by the radio-frequency power generator to the first electrode and the second electrode.
 41. The electrosurgical system of claim 36, wherein the electrosurgical unit is configured to receive and read a stream of serial data from the memory, wherein the stream of serial data comprises data that sets a speed of the pump for a particular radio-frequency power level and a particular fluid flow level.
 42. The electrosurgical system of claim 36, wherein the fluid flow at any of the plurality of fluid flow settings varies according to the level of radio-frequency power provided by the radio-frequency power generator to inhibit at least one of tissue desiccation, electrode sticking, smoke production, or char production.
 43. The electrosurgical system of claim 36, wherein the fluid flow at any of the plurality of fluid flow settings varies according to the level of radio-frequency power provided by the radio-frequency power generator to control electrical dispersion and cooling at an electrode/tissue interface.
 44. The electrosurgical system of claim 36, wherein a relationship between the fluid flow at any of the plurality of fluid flow settings and the level of radio-frequency power provided by the radio-frequency power generator is stored in a memory of the electrosurgical system as an equation or as numerical data points in a database look-up table.
 45. The electrosurgical system of claim 36, wherein the memory of the electrosurgical device comprises a default setting for a radio-frequency power level and a fluid flow setting.
 46. The electrosurgical system of claim 45, wherein the memory of the electrosurgical device comprises operating parameters providing a range of radio-frequency power levels defined by a minimum radio-frequency power level and a maximum radio-frequency power level, and range of fluid flow levels defined by a minimum fluid flow level and a maximum fluid flow level.
 47. An electrosurgical device comprising: a handle; a first shaft member and a second shaft member distal to the handle; a first electrode and a second electrode distal to each of the first shaft member and the second shaft member, respectively, wherein each of the first electrode and the second electrode are stationary and define a spatial gap separation therebetween having a length in a range of 0.1 millimeters (mm) to 4 mm; and at least one fluid outlet adjacent the first electrode and at least one fluid outlet adjacent the second electrode, the at least one fluid outlet adjacent the first electrode and the at least one fluid outlet adjacent the second electrode being spaced apart from one another by a length greater than the spatial gap separation, and each fluid outlet in fluid communication with a fluid passage defined in the handle and the shaft member.
 48. The electrosurgical device of claim 47, wherein the spatial gap separation therebetween has a length in a range of 1 mm to 2.5 mm.
 49. The electrosurgical device of claim 48, wherein the spatial gap separation therebetween has a length in a range of 1.5 mm to 2.3 mm.
 50. The electrosurgical device of claim 47, wherein the first electrode and the second electrode each comprise a blade-shaped member with an elongated substantially planar body having a length significantly greater than a width, and a width significantly greater than a thickness.
 51. The electrosurgical device of claim 50, wherein the length is in a range of 6 mm to 15 mm, the width is in a range of 2 mm to 3 mm, and the thickness is in a range of 0.25 mm to 0.75 mm.
 52. The electrosurgical device of claim 47, wherein at least a portion of the first shaft member and the second shaft member is malleable.
 53. The electrosurgical device of claim 52, wherein a distal portion of each of the first shaft member and the second shaft member is malleable such that the distal portion can be arranged at an angle relative to a longitudinal axis of a proximal portion of each shaft member, and wherein the angle is in a range of 5 degrees to 90 degrees.
 54. The electrosurgical device of claim 53, wherein the angle is in a range of 15 degrees to 45 degrees.
 55. The electrosurgical device of claim 54, wherein the angle is 30 degrees.
 56. The device of claim 47, wherein the first electrode and the second electrodes are configured as bipolar electrodes.
 57. The device of claim 47, wherein at least one of the first electrode or the second electrode is configured as a monopolar electrode. 